Cleared Traditional

K040623 - AMS PERIGEE SYSTEM

K040623 is the FDA 510(k) clearance for AMS PERIGEE SYSTEM by American Medical Systems, Inc.. It is a Class 3 Obstetrics & Gynecology device (product code OTP) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K040623 · American Medical Systems, Inc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
May 2004
Decision
69d
Days
Class 3
Risk

K040623 is an FDA 510(k) clearance for the AMS PERIGEE SYSTEM. Classified as Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed (product code OTP), Class III - Premarket Approval.

Submitted by American Medical Systems, Inc. (Minnetonka, US). The FDA issued a Cleared decision on May 17, 2004 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5980 - the FDA obstetrics and gynecology 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: High-complexity regulatory submission. High regulatory complexity profile. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all American Medical Systems, Inc. devices

Submission Details

510(k) Number K040623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2004
Decision Date May 17, 2004
Days to Decision 69 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 160d · This submission: 69d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 884.5980
Definition Tissue Reinforcement Of The Fibromuscular Layer Of The Pelvic Floor When Surgical Treatment Is Indicated; Procedures Include Anterior And Posterior Vaginal Wall Prolapse Repair And Vaginal Apical Or Uterine Prolapse Repair Performed Transvaginally
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.

Regulatory Peers - OTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed

All 23
Devices cleared under the same product code (OTP) and FDA review panel - the closest regulatory comparables to K040623.
GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEMS
K063562 · Ethicon, Inc. · Feb 2007
MENTOR NOVASILK MESH
K053414 · Mentor Corp. · Dec 2005
UGYTEX SUAL KNIT MESH
K051503 · Sofradim Production · Aug 2005
AMS APOGEE VAULT SUSPENSION SYSTEM
K040537 · American Medical Systems, Inc. · Apr 2004
MODIFICATION TO AMS LARGE PORE POLYPROPYLENE MESH
K040521 · American Medical Systems, Inc. · Mar 2004
AMS LARGE PORE POLYPROPYLENE MESH
K033636 · American Medical Systems, Inc. · Dec 2003