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Codman® 261221

by Integra LifeSciences Production Corporation

Ref 26-1221

Codman® 261221 (26-1221) is a device classified as Class IIa in the EU and Class II in the US made by Integra LifeSciences Production Corporation, registered in EUDAMED on 16 Sep 2026 (Basic UDI-DI B-10381780513599), cleared under FDA 510(k) K183581 on 20 Jan 2019 (1 earlier submission) and listed in FDA GUDID since 1 Apr 2020 (UDI-DI 10381780513599), active as of 9 Nov 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) K183581

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10381780513599 Basic UDI-DI 10381780513599UDI-DIDate16 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10381780513599 UDI-DI Date1 Apr 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK183581 Date20 Jan 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10381780513599 registered 16 Sep 2026 Active
  • FDA 510(k) K183581 decided 20 Jan 2019 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10381780513599 listed 1 Apr 2020 Listed

Recalls

3 recalls · 3 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0373-2026 FDA Class I initiated 26 Sep 2025
    • Ongoing Z-0374-2026 FDA Class I initiated 26 Sep 2025

    Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.

    • Ongoing Z-1716-2025 FDA Class I initiated 11 Apr 2025

    Inadequate weld that can potentially cause the product to disassemble.

Timeline

7 dated events

  1. Cleared FDA 510(k) K791101
  2. Cleared FDA 510(k) K183581
  3. Listed FDA GUDID 10381780513599
  4. Recall initiated FDA recalls Z-1716-2025
  5. Recall initiated FDA recalls Z-0373-2026
  6. Recall initiated FDA recalls Z-0374-2026
  7. Registered EUDAMED B-10381780513599

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
Codman®
Generic name
Automatic cranial perforator, single-use
Device name
Cranial Access
Model / Ref / Catalog
26-1221, 261221
Primary DI / UDI-DI
10381780513599
Basic UDI-DI
B-10381780513599
510(k) Number
FDA product code
HBF
EMDN code
P091304 Cranial perforators, single-use
GMDN term
Automatic cranial perforator, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.4305
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 14 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
26-1221
GUDID
261221
Device classEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Automatic cranial perforator, single-use

Cleared under the same submission (K183581)

Cleared under the same submission (K791101)

Other devices from Integra LifeSciences Production Corporation

See all devices from Integra LifeSciences Production Corporation →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)