ENDURE INDUSTRIES, INC.

FDA Device Registration & Listing · Homer, NY, US · Registration 3013187142

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013187142
FEI Number
3013187142
Entity Name
ENDURE INDUSTRIES, INC.
City/State/Country
Homer, NY, US
Establishment Address
45 North Fulton St, Homer, NY 13077, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Endure Industries, Inc. (Owner Number: 10053392)
Owner / Operator Contact Address
45 North Fulton St, Homer, NY 13077, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K032878
PMA Number
N/A

All Registered Proprietary Names

RPGA Sutures Adult Urine Leg Bag 1000ml, Non-Sterile Oropharyngeal Airway Kit - Bags of 9 Sizes Endure Industries PGCL Sutures Chromic Catgut Sutures Plain Catgut Sutures Endure Specimen Container PGLA Sutures RPGLA Sutures Endure Nasopharyngeal Airway Insulin syringes with needle Luxury Urine Bag 2000 ml, Sterile PGCL Sutures Endure Catgut Safety Blood Collection Sets Endure Cohesive Bandages Breathing Filters

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2023-11-21
NNW Bag, Urine Collection, Leg, For External Use, Non-Sterile Gastroenterology, Urology Class 1 876.5250 2024-04-17
LRW Scissors, General, Surgical General, Plastic Surgery Class 1 878.4800 2023-04-14
CAE Airway, Oropharyngeal, Anesthesiology Anesthesiology Class 1 868.5110 2024-02-20
GAE Snare, Surgical General, Plastic Surgery Class 1 878.4800 2023-04-14
CAH Filter, Bacterial, Breathing-Circuit Anesthesiology Class 2 868.5260 2018-12-26
GAS Suture, Nonabsorbable, Synthetic, Polyester General, Plastic Surgery Class 2 878.5000 2023-11-21
GAL Suture, Absorbable, Natural General, Plastic Surgery Class 2 878.4830 2023-11-21
HMN Suture, Nonabsorable, Ophthalmic Unknown Class 3 N/A 2023-11-21
GAN Suture, Absorbable, Synthetic General, Plastic Surgery Class 2 878.4830 2023-11-21
GAO Suture, Nonabsorbable General, Plastic Surgery Class 2 878.4495 2023-11-21
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2023-11-21
GAW Suture, Nonabsorbable, Synthetic, Polypropylene General, Plastic Surgery Class 2 878.5010 2023-11-21
GAR Suture, Nonabsorbable, Synthetic, Polyamide General, Plastic Surgery Class 2 878.5020 2023-11-21
GAP Suture, Nonabsorbable, Silk General, Plastic Surgery Class 2 878.5030 2023-11-21
FMH Container, Specimen, Sterile Pathology Class 1 864.3250 2024-07-28
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2023-11-21
BTQ Airway, Nasopharyngeal Anesthesiology Class 1 868.5100 2024-03-21
MEG Syringe, Antistick General Hospital Class 2 880.5860 2023-11-21
FMF Syringe, Piston General Hospital Class 2 880.5860 2023-11-21
FAQ Bag, Urine Collection, Leg, For External Use, Sterile Gastroenterology, Urology Class 1 876.5250 2024-04-17
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2023-11-21
GAL Suture, Absorbable, Natural General, Plastic Surgery Class 2 878.4830 2026-03-18
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2023-11-21
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2023-11-21
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2023-04-14
FQM Bandage, Elastic General Hospital Class 1 880.5075 2024-06-26
CAH Filter, Bacterial, Breathing-Circuit Anesthesiology Class 2 868.5260 2023-11-21

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Endure Industries, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K123940 Demetech Corp. DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE 2014-05-30
K050845 ETHICON, Inc. MONOCRYL PLUS ANTIBACTERIAL SUTURE 2005-06-29
K962045 Mallinckrodt Medical ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT 1996-11-26
K241486 Covidien Sofsilk™ Coated Braided Silk Suture 2024-12-03
K092413 Inviro Medical Devices, Inc. INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES 2009-09-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0010-2021 Riverpoint Medical, LLC 2
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 18" P-10 Cutting, Product Number: SV9913, UDI: 20884521153278 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0011-2021 Riverpoint Medical, LLC 2
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-14 Cutting, Product Number: SV935, UDI: 20884521151755 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0012-2021 Riverpoint Medical, LLC 2
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12 Cutting, Product Number: SV426, UDI: 20884521151731 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0013-2021 Riverpoint Medical, LLC 2
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" KV-34 TaperCutting, Product Number: CV919, UDI: 20884521151649 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0014-2021 Riverpoint Medical, LLC 2
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" C-12 Cutting, Product Number: SV2294, UDI 20884521151403 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013187142. Last updated year: 2026. Please use registration number 3013187142 when referencing this establishment in official correspondence.
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