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Prolene 1757g

by Ethicon Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

2 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10705031472747 UDI-DI Date31 Aug 2026ListedStatusListed GUDID: in commercial distribution

Recalls

21 recalls · 2 ongoing · FDA

    • Ongoing Z-1515-2025 FDA Class II initiated 7 Mar 2025 on shared 510(k) K133356

    Identified curing issues with the silicone during the needles manufacturing process.

    • Ongoing Z-1096-2025 FDA Class II initiated 20 Dec 2024

    Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.

  • 19 recalls, same reason

    • Terminated Z-2451-2018 FDA Class II initiated 7 May 2018
    • Terminated Z-2463-2018 FDA Class II initiated 7 May 2018
    • Terminated Z-2465-2018 FDA Class II initiated 7 May 2018
    • Terminated Z-2448-2018 FDA Class II initiated 7 May 2018
    • Terminated Z-2457-2018 FDA Class II initiated 7 May 2018
    • Terminated Z-2455-2018 FDA Class II initiated 7 May 2018
    • Terminated Z-2464-2018 FDA Class II initiated 7 May 2018
    • Terminated Z-2454-2018 FDA Class II initiated 7 May 2018
    • Terminated Z-2456-2018 FDA Class II initiated 7 May 2018
    • Terminated Z-2462-2018 FDA Class II initiated 7 May 2018
    • Terminated Z-2459-2018 FDA Class II initiated 7 May 2018
    • Terminated Z-2461-2018 FDA Class II initiated 7 May 2018
    • Terminated Z-2453-2018 FDA Class II initiated 7 May 2018
    • Terminated Z-2466-2018 FDA Class II initiated 7 May 2018
    • Terminated Z-2458-2018 FDA Class II initiated 7 May 2018
    • Terminated Z-2452-2018 FDA Class II initiated 7 May 2018
    • Terminated Z-2450-2018 FDA Class II initiated 7 May 2018
    • Terminated Z-2449-2018 FDA Class II initiated 7 May 2018
    • Terminated Z-2460-2018 FDA Class II initiated 7 May 2018

    The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Prolene
Generic Name
Polyolefin/fluoropolymer suture, monofilament
Model / Ref / Catalog
1757G, 1757TG
Primary DI / UDI-DI
10705031472747
510(k) Number
FDA Product Code
GAW
GMDN Term
Polyolefin/fluoropolymer suture, monofilament
Device Class
Class II
Regulation Number
878.5010
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K133356)

Show all (12)

Other devices from Ethicon Inc.

  • Coated VICRYL

    Class III

  • Prolene

    Class III

  • Perma-Hand

    Class III

  • Nurolon

    Class III

  • Mersilene

    Class III

  • Coated VICRYL

    Class III

See all devices from Ethicon Inc. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No