Cleared Traditional

K062497 - REPROCESSED TROCARS

K062497 is an FDA 510(k) clearance for REPROCESSED TROCARS, manufactured by Ascent Healthcare Solutions. The device is a Class 2 Gastroenterology & Urology device with product code NLM cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K062497 · Ascent Healthcare Solutions · Gastroenterology & Urology device
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Jan 2007
Decision
159d
Days
Class 2
Risk

K062497 is an FDA 510(k) clearance for the REPROCESSED TROCARS. Classified as Laparoscope, General & Plastic Surgery, Reprocessed (product code NLM), Class II - Special Controls.

Submitted by Ascent Healthcare Solutions (Phoenix, US). The FDA issued a Cleared decision on January 31, 2007 after a review of 159 days - an extended review cycle.

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.

View all Ascent Healthcare Solutions devices

FDA 510(k) Submission Details - K062497

510(k) Number K062497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2006
Decision Date January 31, 2007
Days to Decision 159 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
28d slower than avg
Panel avg: 131d · This submission: 159d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NLM Device Classification - Class 2, Special Controls

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 20
Devices cleared under the same product code (NLM) and FDA review panel - the closest regulatory comparables to K062497.
REPROCESSED TROCARS, MODEL B5LT AND CB5LT
K100080 · Ascent Healthcare Solutions · Mar 2010
REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS
K063788 · Ascent Healthcare Solutions · Oct 2007
REPROCESSED TROCARS
K070059 · Ascent Healthcare Solutions · Oct 2007
VANGUARD REPROCESSED SUTURE PASSER
K053585 · Ascent Healthcare Solutions · Oct 2006
REPROCESSED ENDOSCOPIC TROCAR
K052299 · Sterilmed, Inc. · May 2006
REPROCESSED ENDOSCOPIC TROCAR
K043592 · Sterilmed, Inc. · May 2005