Surgical Simplex P with Tobramycin

510(k) K014199

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	NumberK014199	Date6 May 2003Cleared	StatusActive

2 recalls · 1 ongoing · FDA

- Ongoing Z-0737-2023 FDA Class III initiated 7 Nov 2022
Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish language. Although the Turkish translation is missing, all content within the IFUs is accurate.
- Terminated Z-0467-2007 FDA Unclassified (pre-2012) initiated 7 Nov 2006 on shared 510(k) K014199
The expiration date on the external label is incorrect in that it does not identify the earliest expiration date of the subcomponents. The External label provides for an incorrect longer expiration date than the actual subcomponents will support.

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)