Cleared Traditional

K082006 - AMS SPECTRA CONCEALABLE PENILE PROSTHESIS

K082006 is the FDA 510(k) clearance for AMS SPECTRA CONCEALABLE PENILE PROSTHESIS by American Medical Systems, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FAE) cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K082006 · American Medical Systems, Inc. · Gastroenterology & Urology device
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Oct 2008
Decision
97d
Days
Class 2
Risk

K082006 is an FDA 510(k) clearance for the AMS SPECTRA CONCEALABLE PENILE PROSTHESIS. Classified as Prosthesis, Penile (product code FAE), Class II - Special Controls.

Submitted by American Medical Systems, Inc. (Minnetonka, US). The FDA issued a Cleared decision on October 20, 2008 after a review of 97 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 American Medical Systems, Inc. devices

Submission Details

510(k) Number K082006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2008
Decision Date October 20, 2008
Days to Decision 97 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 130d · This submission: 97d
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 18
Devices cleared under the same product code (FAE) and FDA review panel - the closest regulatory comparables to K082006.
Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device
K183619 · Boston Scientific Corporation · Apr 2019
Rigi10 Malleable Penile Prosthesis
K181673 · Rigicon, Inc. · Apr 2019
AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
K090663 · American Medical Systems, Inc. · Apr 2009
MENTOR GENESIS PENILE PROSTHESIS
K040959 · Mentor Corp. · Oct 2004
AMS AMBICOR PENILE PROSTHESIS
K963328 · American Medical Systems, Inc. · Dec 1996
AMS 650 MALLERABLE PENIEL PROSTHESIS
K951716 · American Medical Systems, Inc. · Jul 1995