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GeniPalm 100-005-152

by Genicon

GeniPalm 100-005-152 is a Class I device made by Genicon, cleared under FDA 510(k) K982472 on 4 Feb 1999 and listed in FDA GUDID since 5 May 2017 (UDI-DI 00877972004912), active as of 23 Oct 2026. 15 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

14 ongoing

This device is named in the recall

Documents

510(k) K982472

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 Number00877972004912 UDI-DI Date5 May 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK982472 Date4 Feb 1999DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K982472 decided 4 Feb 1999 Active
  • FDA GUDID UDI-DI 00877972004912 listed 5 May 2017 Listed

Recalls

15 recalls · 14 ongoing · FDA

  • 14 recalls, same reason

    • Ongoing Z-2270-2020 FDA Class II initiated 21 Aug 2018
    • Ongoing Z-2267-2020 FDA Class II initiated 21 Aug 2018
    • Ongoing Z-2275-2020 FDA Class II initiated 21 Aug 2018
    • Ongoing Z-2274-2020 FDA Class II initiated 21 Aug 2018
    • Ongoing Z-2276-2020 FDA Class II initiated 21 Aug 2018
    • Ongoing Z-2277-2020 FDA Class II initiated 21 Aug 2018
    • Ongoing Z-2272-2020 FDA Class II initiated 21 Aug 2018
    • Ongoing Z-2278-2020 FDA Class II initiated 21 Aug 2018
    • Ongoing Z-2269-2020 FDA Class II initiated 21 Aug 2018
    • Ongoing Z-2273-2020 FDA Class II initiated 21 Aug 2018
    • Ongoing Z-2268-2020 FDA Class II initiated 21 Aug 2018
    • Ongoing Z-2271-2020 FDA Class II initiated 21 Aug 2018
    • Ongoing Z-2266-2020 FDA Class II initiated 21 Aug 2018
    • Ongoing Z-2279-2020 FDA Class II initiated 21 Aug 2018

    There is potential for the plastic optical tip to become detached from the metal shaft.

    • Terminated Z-0622-2009 FDA Unclassified (pre-2012) initiated 25 Sep 2008

    The stainless steel tips on the Genicon 5mm Pyramidal Trocar exhibited contamination that resembled rust and there was also pitting on the tip of the trocar.

Timeline

17 dated events

  1. Recall initiated FDA recalls Z-2276-2020
  2. Recall initiated FDA recalls Z-2277-2020
  3. Recall initiated FDA recalls Z-2272-2020
  4. Recall initiated FDA recalls Z-2278-2020
  5. Recall initiated FDA recalls Z-2269-2020
  6. Recall initiated FDA recalls Z-2273-2020
  7. Recall initiated FDA recalls Z-2268-2020
  8. Recall initiated FDA recalls Z-2271-2020
  9. Recall initiated FDA recalls Z-2266-2020
  10. Recall initiated FDA recalls Z-2279-2020

7 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
GeniPalm
Generic name
Laparoscopic access cannula, single-use
Model / reference
100-005-152
Primary DI / UDI-DI
00877972004912
510(k) Number
FDA product code
GEA
GMDN term
Laparoscopic access cannula, single-use
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution

Related devices

Category: Laparoscopic access cannula, single-use

Cleared under the same submission (K982472)

and 8 more cleared under K982472

Similar devices in this category

Other devices filed under Laparoscopic access cannula, single-use.

Other devices from Genicon

See all devices from Genicon →

Properties

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