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Integra® INS030

by Integra Pain Management

Integra® INS030 is a Class II device made by Integra Pain Management, cleared under FDA 510(k) K961113 on 5 Jun 1996 and listed in FDA GUDID since 19 Nov 2024 (UDI-DI 10381780537311), active as of 23 Oct 2026. 37 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

21 ongoing

This device is named in the recall

Documents

510(k) K961113

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 Number10381780537311 UDI-DI Date19 Nov 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK961113 Date5 Jun 1996DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K961113 decided 5 Jun 1996 Active
  • FDA GUDID UDI-DI 10381780537311 listed 19 Nov 2024 Listed

Recalls

39 recalls · 21 ongoing · FDA

    • Ongoing Z-1873-2024 FDA Class II initiated 17 Apr 2024

    Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device.

  • 11 recalls, same reason

    • Ongoing Z-1198-2024 FDA Class II initiated 19 Jan 2024
    • Ongoing Z-1203-2024 FDA Class II initiated 19 Jan 2024
    • Ongoing Z-1201-2024 FDA Class II initiated 19 Jan 2024
    • Ongoing Z-1193-2024 FDA Class II initiated 19 Jan 2024
    • Ongoing Z-1200-2024 FDA Class II initiated 19 Jan 2024
    • Ongoing Z-1195-2024 FDA Class II initiated 19 Jan 2024
    • Ongoing Z-1199-2024 FDA Class II initiated 19 Jan 2024
    • Ongoing Z-1202-2024 FDA Class II initiated 19 Jan 2024
    • Ongoing Z-1196-2024 FDA Class II initiated 19 Jan 2024
    • Ongoing Z-1197-2024 FDA Class II initiated 19 Jan 2024
    • Ongoing Z-1194-2024 FDA Class II initiated 19 Jan 2024

    A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.

  • 2 recalls, same reason

    • Ongoing Z-0491-2024 FDA Class II initiated 19 Oct 2023
    • Ongoing Z-0492-2024 FDA Class II initiated 19 Oct 2023

    Defect in the outer packaging of the Cranial Access Kits can cause the packaging to split without any additional forces outside compromising the sterility of the device

  • 7 recalls, same reason

    • Ongoing Z-0497-2024 FDA Class II initiated 19 Oct 2023
    • Ongoing Z-0496-2024 FDA Class II initiated 19 Oct 2023
    • Ongoing Z-0499-2024 FDA Class II initiated 19 Oct 2023
    • Ongoing Z-0498-2024 FDA Class II initiated 19 Oct 2023
    • Ongoing Z-0495-2024 FDA Class II initiated 19 Oct 2023
    • Ongoing Z-0494-2024 FDA Class II initiated 19 Oct 2023
    • Ongoing Z-0493-2024 FDA Class II initiated 19 Oct 2023

    Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device

    • Terminated Z-2733-2016 FDA Class II initiated 24 Aug 2016

    Integra LifeSciences has been notified of a medical device recall by Adaptive Surgical, LLC involving their Riverlon" Nylon 3-0 Sutures that are packaged in Integras Cranial Access Kits. It was found that product seals may become open during extreme distribution conditions and render the device unsterile.

    • Terminated Z-2260-2013 FDA Class II initiated 4 Sep 2013 on shared 510(k) K961113

    Integra is recalling certain lots of Cranial Access Kit due to a possibility that the seal integrity of the sterile package may become compromised during shipping.

  • 12 recalls, same reason

    • Terminated Z-0751-2012 FDA Unclassified (pre-2012) initiated 21 Dec 2011
    • Terminated Z-0750-2012 FDA Unclassified (pre-2012) initiated 21 Dec 2011
    • Terminated Z-0748-2012 FDA Unclassified (pre-2012) initiated 21 Dec 2011
    • Terminated Z-0759-2012 FDA Unclassified (pre-2012) initiated 21 Dec 2011
    • Terminated Z-0755-2012 FDA Unclassified (pre-2012) initiated 21 Dec 2011
    • Terminated Z-0752-2012 FDA Unclassified (pre-2012) initiated 21 Dec 2011
    • Terminated Z-0754-2012 FDA Unclassified (pre-2012) initiated 21 Dec 2011
    • Terminated Z-0757-2012 FDA Unclassified (pre-2012) initiated 21 Dec 2011
    • Terminated Z-0753-2012 FDA Unclassified (pre-2012) initiated 21 Dec 2011
    • Terminated Z-0758-2012 FDA Unclassified (pre-2012) initiated 21 Dec 2011
    • Terminated Z-0756-2012 FDA Unclassified (pre-2012) initiated 21 Dec 2011
    • Terminated Z-0749-2012 FDA Unclassified (pre-2012) initiated 21 Dec 2011

    Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine.

    • Terminated Z-2194-2011 FDA Unclassified (pre-2012) initiated 22 Feb 2011

    Outer packaging of Combo Kit was mislabeled with an incorrect lot number.

    • Terminated Z-2171-2011 FDA Unclassified (pre-2012) initiated 22 Feb 2011

    Outer box of Monitoring Kit was mislabeled with the incorrect part number.

    • Terminated Z-2084-2009 FDA Unclassified (pre-2012) initiated 13 Jul 2009

    Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.

    • Terminated Z-1097-04 FDA Unclassified (pre-2012) initiated 19 Mar 2003 on shared 510(k) K961113

    The outer labeling of the convenience kit indicates that an additional bottle of Sodium Chloride (saline) solution is included in the Custom Kit 31176; however, an additional bottle of 1% Xylocaine was included in the Custom Kit.

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

Timeline

41 dated events

  1. Recall initiated FDA recalls Z-1193-2024
  2. Recall initiated FDA recalls Z-1200-2024
  3. Recall initiated FDA recalls Z-1195-2024
  4. Recall initiated FDA recalls Z-1199-2024
  5. Recall initiated FDA recalls Z-1202-2024
  6. Recall initiated FDA recalls Z-1196-2024
  7. Recall initiated FDA recalls Z-1197-2024
  8. Recall initiated FDA recalls Z-1194-2024
  9. Recall initiated FDA recalls Z-1873-2024
  10. Listed FDA GUDID 10381780537311

31 earlier events are in the sections above.

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
Manual cranial rotary handpiece, single-use
Model / Ref / Catalog
INS030
Primary DI / UDI-DI
10381780537311
510(k) Number
FDA product code
HBG
GMDN term
Manual cranial rotary handpiece, single-use
Device class
Class II
Regulation number
882.4300
GUDID distribution status
In Commercial Distribution

Related devices

Category: Manual cranial rotary handpiece, single-use

Cleared under the same submission (K961113)

and 2 more cleared under K961113

Other devices from Integra Pain Management

See all devices from Integra Pain Management →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)