Cleared Traditional

FLEXI-FLATE PENILE IMPLANT

K834347 · Surgitek · Gastroenterology & Urology
Apr 1984
Decision
111d
Days
Class 2
Risk

About This 510(k) Submission

K834347 is an FDA 510(k) clearance for the FLEXI-FLATE PENILE IMPLANT, a Prosthesis, Penile (Class II — Special Controls, product code FAE), submitted by Surgitek (Walker, US). The FDA issued a Cleared decision on April 2, 1984, 111 days after receiving the submission on December 13, 1983. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.3630.

Submission Details

510(k) Number K834347 FDA.gov
FDA Decision Cleared SESE
Date Received December 13, 1983
Decision Date April 02, 1984
Days to Decision 111 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code FAE — Prosthesis, Penile
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.3630

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