Genicon Trocar

510(k) K982472

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK982472	Date4 Feb 1999Cleared	StatusActive

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.

1 jurisdiction

United States — FDA 510(k) Active

510(k)