Cleared Traditional

K122003 - RENEW INSERT

K122003 is an FDA 510(k) clearance for RENEW INSERT, manufactured by Renew Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code PBP cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K122003 · Renew Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2012
Decision
109d
Days
Class 2
Risk

K122003 is an FDA 510(k) clearance for the RENEW INSERT. Classified as Rectal Insert (product code PBP), Class II - Special Controls.

Submitted by Renew Medical, Inc. (Palo Alto, US). The FDA issued a Cleared decision on October 26, 2012 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - 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 Renew Medical, Inc. devices

FDA 510(k) Submission Details - K122003

510(k) Number K122003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2012
Decision Date October 26, 2012
Days to Decision 109 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
22d faster than avg
Panel avg: 131d · This submission: 109d
Pathway characteristics
Predicate-based equivalence.

PBP Device Classification - Class 2, Special Controls

Product Code PBP Rectal Insert
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
Definition Acts As A Barrier To The Passage Of Fecal Matter Through The Rectum.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Gastroenterology & Urology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01475474 Completed Interventional Industry-sponsored

A Study to Evaluate the Safety, Tolerability and Effectiveness of the Renew Insert in Treating Accidental Bowel Leakage

A Multi-Center, Prospective, Non-Randomized Study of the Renew Insert Efficacy, Safety and Tolerability For the Management of Accidental Bowel Leakage Due to Bowel Incontinence

97
Patients (actual)
3
Sites
Treatment
Purpose
Open label
Masking
Condition studied Bowel Incontinence
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Steven D Wexner, MD
Sponsor Renew Medical (industry)
Started 2009-12-01 → Primary completion 2011-11-01 → Completed 2011-12-01
Primary outcome
Co-primary Effectiveness Endpoint: A Relative Percentage Change in Episodes of Accidental Bowel Leakage (ABL) Determined by Comparing Treatment Results to Pre-treatment Results From the Baseline Period as Measured by Daily Diary Recordings.
View full study on ClinicalTrials.gov