Cleared Traditional

PRISMA DISPOSABLE IRRIGATING IRIS HOOK

K874991 · Advanced Surgical Products, Inc. · Ophthalmic
Apr 1988
Decision
133d
Days
Class 1
Risk

About This 510(k) Submission

K874991 is an FDA 510(k) clearance for the PRISMA DISPOSABLE IRRIGATING IRIS HOOK, a Hook, Ophthalmic (Class I — General Controls, product code HNQ), submitted by Advanced Surgical Products, Inc. (Chesterfield, US). The FDA issued a Cleared decision on April 13, 1988, 133 days after receiving the submission on December 2, 1987. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4350.

Submission Details

510(k) Number K874991 FDA.gov
FDA Decision Cleared SESE
Date Received December 02, 1987
Decision Date April 13, 1988
Days to Decision 133 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HNQ — Hook, Ophthalmic
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4350