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Extended Tip Applicator 205115

by Integra Lifesciences Corp.

Ref 205115

Extended Tip Applicator 205115 is an open-surgery adhesive/sealant applicator (EU MDD Class IIa; FDA Class II; FDA product code FMF, Syringe, Piston) made by Integra Lifesciences Corp., registered in EUDAMED on 14 Oct 2026 (Basic UDI-DI B-10381780000150), cleared under FDA 510(k) K091315 on 5 Jun 2009 and listed in FDA GUDID since 29 Dec 2016 (UDI-DI 10381780000150), active as of 25 Oct 2026. 3 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

3 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K091315

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10381780000150 Basic UDI-DI 10381780000150UDI-DIDate14 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10381780000150 UDI-DI Date29 Dec 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK091315 Date5 Jun 2009DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10381780000150 registered 14 Oct 2026 Active
  • FDA 510(k) K091315 decided 5 Jun 2009 Active
  • FDA GUDID UDI-DI 10381780000150 listed 29 Dec 2016 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

6 dated events

  1. Cleared FDA 510(k) K091315
  2. Listed FDA GUDID 10381780000150
  3. Recall initiated FDA recalls Z-1958-2025
  4. Recall initiated FDA recalls Z-1960-2025
  5. Recall initiated FDA recalls Z-1959-2025
  6. Registered EUDAMED B-10381780000150

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Extended Tip Applicator
Generic name
Open-surgery adhesive/sealant applicator, dual-channel
Model / Ref / Catalog
205115
Primary DI / UDI-DI
10381780000150
Basic UDI-DI
B-10381780000150
510(k) Number
FDA product code
FMF
EMDN code
K0199 Endotherapy devices - other
GMDN term
Open-surgery adhesive/sealant applicator, dual-channel
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
880.5860
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Size
Length — 15 Centimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

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 ENDOTHERAPY DEVICES - OTHER.

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 (20, all answered No)