Adult Resectoscope

510(k) K890328

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	NumberK890328	Date6 Feb 1990Cleared	StatusActive

7 recalls · 6 ongoing · FDA

2 recalls, same reason
- Ongoing Z-3300-2026 FDA Class II initiated 24 Aug 2026
- Ongoing Z-3299-2026 FDA Class II initiated 24 Aug 2026
There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.
- Ongoing Z-2720-2026 FDA Class II initiated 5 May 2026 on shared 510(k) K890328
Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
2 recalls, same reason
- Ongoing Z-2140-2025 FDA Class II initiated 18 Jun 2025
- Ongoing Z-2139-2025 FDA Class II initiated 18 Jun 2025
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
- Ongoing Z-0568-2024 FDA Class II initiated 2 Oct 2023 on shared 510(k) K890328
Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes.
- Terminated Z-1952-2018 FDA Class II initiated 17 Apr 2018 on shared 510(k) K890328
There is a potential for the cord to spark and cause a fire.

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

1 jurisdiction

United States — FDA 510(k) Active

510(k)