Skip to content

Seare Biomedical Silicone Sheeting

by Seare Biomedical Corp.

510(k) K983041

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 26 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK983041 Date30 Sep 1998ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 26 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MIB
Device Class
Class II
Regulation
21 CFR Part 874.3620
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Other devices from Seare Biomedical Corp.

See all devices from Seare Biomedical Corp. →