Cleared Traditional

STORZ DP4800 DELUXE , STORZ DP4801 BASIC W/REFLUX, DP4801 BASIC POSTERIOR VITRECTOMY PACK WITH VARIABLE PORT CUTTER & RX

K954816 · Storz Instrument Co. · Ophthalmic

Mar 1996

Decision

136d

Days

Class 2

Risk

About This 510(k) Submission

K954816 is an FDA 510(k) clearance for the STORZ DP4800 DELUXE , STORZ DP4801 BASIC W/REFLUX, DP4801 BASIC POSTERIOR VITRECTOMY PACK WITH VARIABLE PORT CUTTER & RX, a Instrument, Vitreous Aspiration And Cutting, Ac-powered (Class II — Special Controls, product code HQE), submitted by Storz Instrument Co. (St. Louis, US). The FDA issued a Cleared decision on March 4, 1996, 136 days after receiving the submission on October 20, 1995. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4150.

Submission Details

510(k) Number	K954816 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 20, 1995
Decision Date	March 04, 1996
Days to Decision	136 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF