SPECTRA MEDICAL DEVICES, LLC
Registration 1224960FEI 3000204727WILMINGTON, MA
Owner/operator: SPECTRA MEDICAL DEVICES, LLC
- Develop Specifications But Do Not Manufacture At This Facility
- Manufacture Medical Device
- Manufacture Medical Device for Another Party (Contract Manufacturer)
- 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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The 2026 window
- Oct 1Window opens91 days left
- Nov 3Where you stand58 days left
- Dec 1Our pay-by date30 days left
- Dec 15Two weeks left16 days left
- Dec 23Holiday week8 days left
- Dec 29Two days left2 days left
- Dec 31Window closes0 days left
- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 24
- Added, last 12 months
- 1
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 24
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| CAZ | Disposable Epidural Anesthesia TrayAnesthesia Conduction Kit | Class 2 | 21 CFR 868.5140 | K880181 |
| GXD | NBD Disposable RF CannulaGenerator, Lesion, Radiofrequency | Class 2 | 21 CFR 882.4400 | K032196 |
| KNW | Spectra Soft Tissue Biopsy NeedlesInstrument, Biopsy | Class 2 | 21 CFR 876.1075 | K142791 |
| DYB | Spectra Guidewire Introducer NeedleIntroducer, Catheter | Class 2 | 21 CFR 870.1340 | K082580 |
| BSP | SPECTRA Sonic Block Chiba NeedleNeedle, Conduction, Anesthetic (W/Wo Introducer) | Class 2 | 21 CFR 868.5150 | K163292 |
| BSP | SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction NeedleNeedle, Conduction, Anesthetic (W/Wo Introducer) | Class 2 | 21 CFR 868.5150 | K151069 |
| BSP | Atraumatic Pencil Point Spinal NeedleNeedle, Conduction, Anesthetic (W/Wo Introducer) | Class 2 | 21 CFR 868.5150 | K945965 |
| BSP | Epidural Anesthesia NeedleNeedle, Conduction, Anesthetic (W/Wo Introducer) | Class 2 | 21 CFR 868.5150 | K854816 |
| FMI | Vascular Access Port Huber Point Infusion NeedleNeedle, Hypodermic, Single Lumen | Class 2 | 21 CFR 880.5570 | K884792 |
| MIA | Spectra Spinal NeedlesNeedle, Spinal, Short Term | Class 2 | 21 CFR 868.5150 | K971645 |
| GXI | NBD Disposable RF CannulaProbe, Radiofrequency Lesion | Class 2 | 21 CFR 882.4725 | K032196 |
| NGT | Sodium Chloride Inj. 0.9% USP 5ml and 10ml AmpuleSaline, Vascular Access FlushAdded Dec 2, 2025 | Class 2 | 21 CFR 880.5200 | K103740 |
and 12 more on your full dossier
What changed
- Dec 2, 2025Listing added: NGT — Sodium Chloride Inj. 0.9% USP 5ml and 10ml Ampule (K103740)