Cleared Traditional

K012644 - REPROCESSED TROCARS AND CANNULAS (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K012644 · Surgical Instruments Service and Savings, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Jul 2002
Decision
350d
Days
Class 2
Risk

K012644 is an FDA 510(k) clearance for the REPROCESSED TROCARS AND CANNULAS. Classified as Laparoscope, General & Plastic Surgery, Reprocessed (product code NLM), Class II - Special Controls.

Submitted by Surgical Instruments Service and Savings, Inc. (Phoenix, US). The FDA issued a Cleared decision on July 29, 2002 after a review of 350 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K012644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2001
Decision Date July 29, 2002
Days to Decision 350 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
220d slower than avg
Panel avg: 130d · This submission: 350d
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.