ENDURE INDUSTRIES, INC.
Registration 3013187142FEI 3013187142Homer, NY
Owner/operator: Endure Industries, Inc.
- Develop Specifications But Do Not Manufacture At This Facility
- Manufacture Medical Device
- 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
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- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 53
- Added, last 12 months
- 15
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 53
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| HMN | Chromic Catgut SuturesSuture, Nonabsorable, Ophthalmic | Class 3 | — | K982646 |
| CCK | Endure ETCO2 Cannula with Bite BlockAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAdded Aug 9, 2026 | Class 2 | 21 CFR 868.1400 | K213767 |
| CAH | Bacterial Viral FilterFilter, Bacterial, Breathing-Circuit | Class 2 | 21 CFR 868.5260 | K132709 |
| CAH | Endure IndustriesFilter, Bacterial, Breathing-Circuit | Class 2 | 21 CFR 868.5260 | K151498 |
| CAH | Breathing FiltersFilter, Bacterial, Breathing-Circuit | Class 2 | 21 CFR 868.5260 | K032878 |
| JOJ | Indicator, Physical/Chemical Sterilization ProcessGeneral Hospital | Class 2 | 21 CFR 880.2800 | K180661 |
| FMI | Butterfly Needles (With / without Needles)Needle, Hypodermic, Single LumenAdded Jul 26, 2026 | Class 2 | 21 CFR 880.5570 | K170276 |
| FMI | Safety Blood Collection SetsNeedle, Hypodermic, Single Lumen | Class 2 | 21 CFR 880.5570 | K181508 |
| DQA | Fingertip Pulse OximeterOximeterAdded Jul 26, 2026 | Class 2 | 21 CFR 870.2700 | K151024 |
| FPA | Butterfly Needles (With / without Needles)Set, Administration, IntravascularAdded Jul 26, 2026 | Class 2 | 21 CFR 880.5440 | K170276 |
| GAL | Endure CatgutSuture, Absorbable, NaturalAdded Mar 18, 2026 | Class 2 | 21 CFR 878.4830 | K000542 |
| GAL | Chromic Catgut SuturesSuture, Absorbable, Natural | Class 2 | 21 CFR 878.4830 | K982646 |
and 41 more on your full dossier
What changed
- Aug 9, 2026Listing added: CCK — Endure ETCO2 Cannula with Bite Block (K213767)
- Jul 26, 2026Listing added: FMI — Butterfly Needles (With / without Needles) (K170276)
- Jul 26, 2026Listing added: DQA — Fingertip Pulse Oximeter (K151024)
- Jul 26, 2026Listing added: FPA — Butterfly Needles (With / without Needles) (K170276)
- Mar 18, 2026Listing added: GAL — Endure Catgut (K000542)
- Aug 9, 2026Listing added: CAT — Endure ETCO2 Cannula with Bite Block (K213767)
- Aug 11, 2026Listing added: CAI — Endure breathing cirucit with connectors and adapters
- Aug 11, 2026Listing added: KCN — Endure ear wick
- Jul 26, 2026Listing added: BSJ — Anesthesia mask
- Jul 26, 2026Listing added: BYG — Oxygen Mask & Tubing
- Jul 26, 2026Listing added: JOK — Bandage Scissors
- Aug 9, 2026Listing added: LYA — Endure Nasal Packing
- Jul 26, 2026Listing added: GDT — Skin Stapler Remover
- Aug 9, 2026Listing added: GAX — Endure Tourniquets
- Aug 11, 2026Listing added: BYX — Endure gas sampling line