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Extended Tip Applicator 201108

by Integra Lifesciences Corp.

Extended Tip Applicator 201108 is an open-surgery adhesive/sealant applicator (FDA Class II; FDA product code FMF, Syringe, Piston) made by Integra Lifesciences Corp., cleared under FDA 510(k) K091315 on 5 Jun 2009 and listed in FDA GUDID since 5 Jun 2015 (UDI-DI 10381780000167), active as of 23 Oct 2026. 3 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 ongoing

This device is named in the recall

Documents

510(k) K091315

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10381780000167 UDI-DI Date5 Jun 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK091315 Date5 Jun 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K091315 decided 5 Jun 2009 Active
  • FDA GUDID UDI-DI 10381780000167 listed 5 Jun 2015 Listed

Recalls

3 recalls · 3 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-1958-2025 FDA Class I initiated 22 May 2025
    • Ongoing Z-1960-2025 FDA Class I initiated 22 May 2025
    • Ongoing Z-1959-2025 FDA Class I initiated 22 May 2025

    Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.

Timeline

5 dated events

  1. Cleared FDA 510(k) K091315
  2. Listed FDA GUDID 10381780000167
  3. Recall initiated FDA recalls Z-1958-2025
  4. Recall initiated FDA recalls Z-1960-2025
  5. Recall initiated FDA recalls Z-1959-2025

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Extended Tip Applicator
Generic name
Open-surgery adhesive/sealant applicator, dual-channel
Model / Ref / Catalog
201108
Primary DI / UDI-DI
10381780000167
510(k) Number
FDA product code
FMF
GMDN term
Open-surgery adhesive/sealant applicator, dual-channel
Device class
Class II
Regulation number
880.5860
GUDID distribution status
In Commercial Distribution
Size
Length — 8 Centimeter

Related devices

Category: Open-surgery adhesive/sealant applicator, dual-channel

Cleared under the same submission (K091315)

Similar devices in this category

Other devices filed under Open-surgery adhesive/sealant applicator, dual-channel.

Other devices from Integra Lifesciences Corp.

See all devices from Integra Lifesciences Corp. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)