STELLMACHER INSTRUMENTS INC
Registration 3029754081FEI 3029754081Clermont, FL
Owner/operator: Stellmacher Instruments Inc
- Repack or Relabel Medical Device
Renewal due by December 31, 2026
Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.
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- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 30
- Added, last 12 months
- 30
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The steps, in order
Pay FDA's annual feeYou
Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.
FDA: registration and listing payment processWait for the payment confirmation numberYou
FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.
FDA: registration and listing payment processRenew the registration in FDA's systemYou
Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.
FDA: device registration and listingReview every listingYou
In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.
FDA: device registration and listing
Every listed device 30
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| IKD | Connecting CableCable, ElectrodeAdded Jul 16, 2026 | Class 2 | 21 CFR 890.1175 | — |
| GEI | Disposable Electrosurgical PencilElectrosurgical, Cutting & Coagulation & AccessoriesAdded Jul 15, 2026 | Class 2 | 21 CFR 878.4400 | K221815 |
| GEI | Electrosurgical GeneratorElectrosurgical, Cutting & Coagulation & AccessoriesAdded Jul 15, 2026 | Class 2 | 21 CFR 878.4400 | K162034 |
| GEI | Electrosurgical PadsElectrosurgical, Cutting & Coagulation & AccessoriesAdded Jul 15, 2026 | Class 2 | 21 CFR 878.4400 | K233615 |
| GAP | Silk 2/0, 3/8 reverse cutting 24mm, 75cmSuture, Nonabsorbable, SilkAdded Jul 16, 2026 | Class 2 | 21 CFR 878.5030 | K232355 |
| GAR | Black Nylon 10/0, 3/8 round bodied 5mm, 30cmSuture, Nonabsorbable, Synthetic, PolyamideAdded Jul 16, 2026 | Class 2 | 21 CFR 878.5020 | K212603 |
| GAT | Polyester 2/0, 3/8 reverse cutting 30mm, 75 cmSuture, Nonabsorbable, Synthetic, PolyethyleneAdded Jul 16, 2026 | Class 2 | 21 CFR 878.5000 | K231183 |
| GAW | Polypropylene 3/0 1/2 round bodied 20mm, 75cmSuture, Nonabsorbable, Synthetic, PolypropyleneAdded Jul 16, 2026 | Class 2 | 21 CFR 878.5010 | K230746 |
| HMX | 5 Lachrymal cannula, curved, beveled, 23 gaCannula, OphthalmicAdded Jul 4, 2026 | Class 1 | 21 CFR 886.4350 | — |
| GEA | 11 Pcs Liposuction Cannula Set 30cmCannula, Surgical, General & Plastic SurgeryAdded Apr 6, 2026 | Class 1 | 21 CFR 878.4800 | — |
| HNW | Castroviejo Caliper, 20 mmDilator, LachrymalAdded Jul 9, 2026 | Class 1 | 21 CFR 886.4350 | — |
| GDI | Agris - Dingman Breast Dissectors Length 33 cm, leftDissector, Surgical, General & Plastic SurgeryAdded Jul 14, 2026 | Class 1 | 21 CFR 878.4800 | — |
and 18 more on your full dossier
What changed
- Jul 16, 2026Listing added: IKD — Connecting Cable
- Jul 15, 2026Listing added: GEI — Disposable Electrosurgical Pencil (K221815)
- Jul 15, 2026Listing added: GEI — Electrosurgical Generator (K162034)
- Jul 15, 2026Listing added: GEI — Electrosurgical Pads (K233615)
- Jul 16, 2026Listing added: GAP — Silk 2/0, 3/8 reverse cutting 24mm, 75cm (K232355)
- Jul 16, 2026Listing added: GAR — Black Nylon 10/0, 3/8 round bodied 5mm, 30cm (K212603)
- Jul 16, 2026Listing added: GAT — Polyester 2/0, 3/8 reverse cutting 30mm, 75 cm (K231183)
- Jul 16, 2026Listing added: GAW — Polypropylene 3/0 1/2 round bodied 20mm, 75cm (K230746)
- Jul 4, 2026Listing added: HMX — 5 Lachrymal cannula, curved, beveled, 23 ga
- Apr 6, 2026Listing added: GEA — 11 Pcs Liposuction Cannula Set 30cm
- Jul 9, 2026Listing added: HNW — Castroviejo Caliper, 20 mm
- Jul 14, 2026Listing added: GDI — Agris - Dingman Breast Dissectors Length 33 cm, left
- Jul 4, 2026Listing added: HNR — Abdullayev DMEK grasping forceps, flat handle overall length 82 mm, stainless steel
- Jul 9, 2026Listing added: GDZ — Chuck handle, Round Serrated, overall length 10 cm
- Jul 9, 2026Listing added: HNQ — Akahoshi Pre-Choper, for 2.2 mm incisions, semi sharp, overall length 11.5 cm
- Jul 9, 2026Listing added: KDD — Blepharoplasty Ophthalmic Set
- Jul 14, 2026Listing added: NWV — ALLIGATOR GRASPING FORCEPS
- May 12, 2026Listing added: CCW — Fiber Optic Laryngoscope Reusable set Mac + Miller Set of 15
- Jul 9, 2026Listing added: HMQ — Abdullayev scleral marker for keratoplasty double-ended titanium handle/stainless steel tips overall length 153 mm
- Jul 14, 2026Listing added: FZZ — Areola Markers Reusable ACKERMANN Areola Marker (10.5 cm)
- Jul 14, 2026Listing added: LXH — BETHUNE RIB SHEAR S-shaped handle, blunt, overall length 34cm
- Jul 9, 2026Listing added: HNL — Bowman Lacrimal probe, stainless steel overall length 13 cm
- Jul 9, 2026Listing added: HNJ — Beyer Atticus punch, delicate, shaft size 18 cm
- Jul 14, 2026Listing added: GAD — AUFRICHT Nasal Retractors Blade 7 x 45, length 18 cm
- Jul 6, 2026Listing added: HNI — Bunge evisceration spoon, small, overall length 13 cm
- Jul 9, 2026Listing added: HTX — BEYER BONE RONGEURS FORCEPS Jaw width 3mm, overall length 18cm
- Jun 23, 2026Listing added: JOK — Mayo Scissors 14Cm Straight
- Jul 6, 2026Listing added: HNF — Barraquer De weckers scissors, overall length 6 cm
- Jul 9, 2026Listing added: HND — Barraquer Iris spatula, flat tip 0.25 mm, overall length 12.5 cm
- Jul 6, 2026Listing added: HNC — Aspiration speculum for LASIK, with ports for removing fluid, blade 15 mm