Surgicount Safety-Sponge System

510(k) K060076

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 closed

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	NumberK060076	Date14 Mar 2006Cleared	StatusActive

3 recalls · FDA

- Terminated Z-1452-2022 FDA Class II initiated 15 Jun 2022
When scanning sponges out after a surgical procedure, an error may allow for a duplicate sponge to be counted without the prompt to make a case note and allowing the case to close. The software update will prevent the occurrence of this error.
- Terminated Z-1379-2016 FDA Class II initiated 21 Mar 2016
The affected scanner does not correctly interact with the SC360 software. When docked pre/postoperatively, the affected SurgiCounter scanner may display an error message (code=2). Also, the SurgiCounter scanner software version number is not appropriately displayed in the SC360 application during installation.
- Terminated Z-0986-2015 FDA Class II initiated 16 Jun 2013
Faulty SurgiCounter Charging Cradle can prevent the scanner from charging or downloading information after a procedure.

1 jurisdiction

United States — FDA 510(k) Active

510(k)