ETHICON, LLC
Registration 3007791599FEI 3007791599Guaynabo, PR
Owner/operator: ETHICON, LLC
- Manufacture 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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The 2026 window
- Oct 1Window opens91 days left
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- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 45
- Added, last 12 months
- 5
FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page
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 45
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| GCJ | ETHICON ENDOSUTURE HolderLaparoscope, General & Plastic Surgery | Class 2 | 21 CFR 876.1500 | K963329 |
| DXZ | PROLENE on TEFLON Pledget ButtressPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | Class 2 | 21 CFR 870.3470 | K811872 |
| DXZ | TFE Polymer PledgetsPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | Class 2 | 21 CFR 870.3470 | — |
| GDW | SECURESTRAP Open Absorbable Strap Fixation DeviceStaple, Implantable | Class 2 | 21 CFR 878.4750 | K123114 |
| GDW | Ethicon SECURESTRAP Absorbable Strap Fixation DeviceStaple, Implantable | Class 2 | 21 CFR 878.4750 | K093845 |
| GAL | CHROMIC and PLAIN GUTSuture, Absorbable, Natural | Class 2 | 21 CFR 878.4830 | K946173 |
| GAN | MONOCRYL (undyed)Suture, Absorbable, Synthetic | Class 2 | 21 CFR 878.4830 | K964072 |
| GAN | CAPROFYLSuture, Absorbable, Synthetic | Class 2 | 21 CFR 878.4830 | K960653 |
| GAM | Coated VICRYL PlusSuture, Absorbable, Synthetic, Polyglycolic Acid | Class 2 | 21 CFR 878.4493 | K032420 |
| GAM | STRATAFIX Spiral PDS Plus Knotless Tissue Control DevicesSuture, Absorbable, Synthetic, Polyglycolic AcidAdded Jun 2, 2026 | Class 2 | 21 CFR 878.4493 | K252743 |
| GAM | Coated VICRYL Plus Antibacterial (Polyglactin 910) Absorbable SutureSuture, Absorbable, Synthetic, Polyglycolic Acid | Class 2 | 21 CFR 878.4493 | K181652 |
| GAM | VICRYL RAPIDESuture, Absorbable, Synthetic, Polyglycolic Acid | Class 2 | 21 CFR 878.4493 | K033746 |
and 33 more on your full dossier
What changed
- Jun 2, 2026Listing added: GAM — STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices (K252743)
- Mar 9, 2026Listing added: GAM — MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture (K253852)
- May 5, 2026Listing added: GAW — STRATAFIX Spiral PRONOVA Bidirectional Knotless Tissue Control Device (K253572)
- Jun 2, 2026Listing added: NEW — STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices (K252047)
- Nov 24, 2025Listing added: NEW — PDS Plus Antibacterial Suture (K243897)