Ascon Ophthalmic Sponge

by Ascon Medical Instruments, Ltd. 510(k)

Active United States

510(k) K852055

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK852055	Date4 Sep 1985Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number: K852055
FDA Product Code: HOZ

Device Class: Class II
Regulation: 21 CFR Part 886.4790
Advisory Committee: Ophthalmic
FDA Decision: SESE Substantially Equivalent

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