Cleared Traditional

K132629 - REPROCESSED DILATING TIP TROCARS

K132629 is the FDA 510(k) clearance for REPROCESSED DILATING TIP TROCARS by Stryker Sustainability Solutions. It is a Class 2 Gastroenterology & Urology device (product code NLM) cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K132629 · Stryker Sustainability Solutions · Gastroenterology & Urology device
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Dec 2013
Decision
131d
Days
Class 2
Risk

K132629 is an FDA 510(k) clearance for the REPROCESSED DILATING TIP TROCARS. Classified as Laparoscope, General & Plastic Surgery, Reprocessed (product code NLM), Class II - Special Controls.

Submitted by Stryker Sustainability Solutions (Tempe, US). The FDA issued a Cleared decision on December 31, 2013 after a review of 131 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - 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.

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Submission Details

510(k) Number K132629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2013
Decision Date December 31, 2013
Days to Decision 131 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 130d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NLM Laparoscope, General & Plastic Surgery, Reprocessed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition The "endoscope And Accessories, Reprocessed" Is Intended To Provide Access, Illumination, And Allow Observation Or Manipulation Of Body Cavities, Hollow Organs, And Canals. This Device Is Indicated For Reuse/reprocessing. Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.pdf).
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 - NLM Laparoscope, General & Plastic Surgery, Reprocessed

All 9
Devices cleared under the same product code (NLM) and FDA review panel - the closest regulatory comparables to K132629.
Reprocessed Endoscopic Trocars and Sleeves
K201511 · Stryker Sustainability Solutions · Jul 2020
Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer
K182828 · Surgical Instrument Service and Savings, Inc. · Apr 2019
REPROCESSED CLOSURE SYSTEM
K133414 · Sterilmed, Inc. · Jan 2014
REPROCESSED ENDOSCOPIC TROCARS
K121240 · Sterilmed, Inc. · Jun 2012
REPROCESSED ENDOSCOPIC TROCARS
K111002 · Sterilmed, Inc. · Jul 2011
REPROCESSED ENDOSCOPIC TROCAR
K052299 · Sterilmed, Inc. · May 2006