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Integra® 00290011

by Integra LifeSciences Production Corporation

Integra® 00290011 is a Class II device made by Integra LifeSciences Production Corporation, cleared under FDA 510(k) K864380 on 19 Nov 1986 and listed in FDA GUDID since 23 Aug 2016 (UDI-DI 10381780251279), active as of 23 Oct 2026. 8 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

None ongoing

8 closed

Documents

510(k) K864380

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 Number10381780251279 UDI-DI Date23 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK864380 Date19 Nov 1986DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K864380 decided 19 Nov 1986 Active
  • FDA GUDID UDI-DI 10381780251279 listed 23 Aug 2016 Listed

Recalls

8 recalls · FDA

  • 8 recalls, same reason

    • Terminated Z-0373-2012 FDA Unclassified (pre-2012) initiated 10 Oct 2011
    • Terminated Z-0376-2012 FDA Unclassified (pre-2012) initiated 10 Oct 2011
    • Terminated Z-0378-2012 FDA Unclassified (pre-2012) initiated 10 Oct 2011
    • Terminated Z-0377-2012 FDA Unclassified (pre-2012) initiated 10 Oct 2011
    • Terminated Z-0381-2012 FDA Unclassified (pre-2012) initiated 10 Oct 2011
    • Terminated Z-0374-2012 FDA Unclassified (pre-2012) initiated 10 Oct 2011
    • Terminated Z-0380-2012 FDA Unclassified (pre-2012) initiated 10 Oct 2011
    • Terminated Z-0375-2012 FDA Unclassified (pre-2012) initiated 10 Oct 2011

    Headlight assembly (module) may become loose and separate from the headband assembly

Timeline

10 dated events

  1. Cleared FDA 510(k) K864380
  2. Recall initiated FDA recalls Z-0373-2012
  3. Recall initiated FDA recalls Z-0376-2012
  4. Recall initiated FDA recalls Z-0378-2012
  5. Recall initiated FDA recalls Z-0377-2012
  6. Recall initiated FDA recalls Z-0381-2012
  7. Recall initiated FDA recalls Z-0374-2012
  8. Recall initiated FDA recalls Z-0380-2012
  9. Recall initiated FDA recalls Z-0375-2012
  10. Listed FDA GUDID 10381780251279

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Integra®
Generic name
General-purpose light source
Model / Ref / Catalog
00290011, 290011
Primary DI / UDI-DI
10381780251279
510(k) Number
FDA product code
FST
GMDN term
General-purpose light source
Device class
Class II
Regulation number
878.4580
GUDID distribution status
In Commercial Distribution

Related devices

Category: General-purpose light source

Cleared under the same submission (K864380)

and 8 more cleared under K864380

Similar devices

Other devices filed under FDA product code FST (LIGHT, SURGICAL, FIBEROPTIC).

Other devices from Integra LifeSciences Production Corporation

See all devices from Integra LifeSciences Production Corporation →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)