Cleared Traditional

K834347 - FLEXI-FLATE PENILE IMPLANT

K834347 is the FDA 510(k) clearance for FLEXI-FLATE PENILE IMPLANT by Surgitek. It is a Class 2 Gastroenterology & Urology device (product code FAE) cleared through the Traditional 510(k) pathway after a 111-day FDA review.

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

K834347 is an FDA 510(k) clearance for the FLEXI-FLATE PENILE IMPLANT. Classified as Prosthesis, Penile (product code FAE), Class II - Special Controls.

Submitted by Surgitek (Walker, US). The FDA issued a Cleared decision on April 2, 1984 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.3630 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Surgitek devices

Submission Details

510(k) Number K834347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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 -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 130d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FAE Prosthesis, Penile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.3630
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FAE Prosthesis, Penile

All 14
Devices cleared under the same product code (FAE) and FDA review panel - the closest regulatory comparables to K834347.
700 ULTREX PENILE PROSTHESIS 12MM DIAMETER
K901482 · American Medical Systems, Inc. · Jun 1990
AMS DYNAFLEX SELF CONTAINED PENILE PROSTHESIS
K896941 · American Medical Systems, Inc. · Mar 1990
BARD ESKA JONAS SILICONE-SILVER PENILE PROSTHESIS
K864040 · C.R. Bard, Inc. · Oct 1986
AMS MALLEABLE PENILE PROSTHESIS
K831660 · American Medical Systems, Inc. · Aug 1983
INFLATABLE PENILE PROSTH. - CYLINDER
K830048 · American Medical Systems, Inc. · Apr 1983
THE INFLATABLE PENILE PROSTHESIS
K821628 · American Medical Systems, Inc. · Aug 1982