Optima Coil System

510(k) K172390

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	NumberK172390	Date18 Feb 2018Cleared	StatusActive

4 recalls · 4 ongoing · FDA

- Ongoing Z-1988-2025 FDA Class II initiated 8 May 2025
Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.
- Ongoing Z-1041-2024 FDA Class II initiated 3 Jan 2024
Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material which caused the corrosion was identified as remnants of solder flux residue remaining on the hypotube component of the delivery pusher. Due to the location of the delivery pusher within the delivery system, it is possible for the discoloration to mechanically break off from the delivery pusher, leaving the potential for the material to flow through the delivery system (i.e. microcatheter), and into the patient vasculature causing foreign emboli.
- Ongoing Z-0103-2023 FDA Class II initiated 7 Sep 2022
Product pouch label does not match up with carton label
- Ongoing Z-1680-2022 FDA Class II initiated 26 Jul 2022
Products were released to customers prior to the approval and release of a test report authorizing the use of an existing material from an alternate supplier.

1 jurisdiction

United States — FDA 510(k) Active

510(k)