Cleared Traditional

K834347 - FLEXI-FLATE PENILE IMPLANT

K834347 is an FDA 510(k) clearance for FLEXI-FLATE PENILE IMPLANT, manufactured by Surgitek. The device is a Class 2 Gastroenterology & Urology device with 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

FDA 510(k) Submission Details - K834347

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 131d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FAE Device Classification - Class 2, Special Controls

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 28
Devices cleared under the same product code (FAE) and FDA review panel - the closest regulatory comparables to K834347.
MENTOR CORPORAL DILATORS
K860517 · Mentor Corp. · Mar 1986
OMNI PHASE PENILE PROSTHESIS
K850019 · Dacomed Corp. · Apr 1985
MALLEABLE PENILE PROSTHESIS
K843280 · Mentor Corp. · Oct 1984
ESKA JONAS SILICON-SILVER PENILE
K834504 · Dacomed Corp. · Feb 1984
SURGIKEK PENILE PROSTHESIS TAIL EXTEND
K832043 · Medical Engineering Corp. · Oct 1983
AMS MALLEABLE PENILE PROSTHESIS
K831660 · American Medical Systems, Inc. · Aug 1983