Cleared Traditional

K083722 - ASCEND

K083722 is the FDA 510(k) clearance for ASCEND by Caldera Medical, Inc.. It is a Class 3 Obstetrics & Gynecology device (product code OTP) cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K083722 · Caldera Medical, Inc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Mar 2009
Decision
106d
Days
Class 3
Risk

K083722 is an FDA 510(k) clearance for the ASCEND. Classified as Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed (product code OTP), Class III - Premarket Approval.

Submitted by Caldera Medical, Inc. (Agoura Hills, US). The FDA issued a Cleared decision on March 31, 2009 after a review of 106 days - within the typical 510(k) review window.

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 Caldera Medical, Inc. devices

Submission Details

510(k) Number K083722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2008
Decision Date March 31, 2009
Days to Decision 106 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 160d · This submission: 106d
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 24
Devices cleared under the same product code (OTP) and FDA review panel - the closest regulatory comparables to K083722.
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K082730 · American Medical Systems, Inc. · Nov 2008