Cleared Traditional

K060676 - NES REPROCESSED ENDOSCOPIC TROCAR

K060676 is an FDA 510(k) clearance for NES REPROCESSED ENDOSCOPIC TROCAR, manufactured by Northeast Scientific, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code NLM cleared through the Traditional 510(k) pathway after a 542-day FDA review.

K060676 · Northeast Scientific, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2007
Decision
542d
Days
Class 2
Risk

K060676 is an FDA 510(k) clearance for the NES REPROCESSED ENDOSCOPIC TROCAR. Classified as Laparoscope, General & Plastic Surgery, Reprocessed (product code NLM), Class II - Special Controls.

Submitted by Northeast Scientific, Inc. (Waterbury, US). The FDA issued a Cleared decision on September 7, 2007 after a review of 542 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Northeast Scientific, Inc. devices

FDA 510(k) Submission Details - K060676

510(k) Number K060676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2006
Decision Date September 07, 2007
Days to Decision 542 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
412d slower than avg
Panel avg: 130d · This submission: 542d
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 13
Devices cleared under the same product code (NLM) and FDA review panel - the closest regulatory comparables to K060676.
REPROCESSED DILATING TIP TROCARS
K132629 · Stryker Sustainability Solutions · Dec 2013
REPROCESSED ENDOSCOPIC TROCARS
K121240 · Sterilmed, Inc. · Jun 2012
REPROCESSED ENDOSCOPIC TROCARS
K111002 · Sterilmed, Inc. · Jul 2011
REPROCESSED ENDOSCOPIC TROCAR
K052299 · Sterilmed, Inc. · May 2006
REPROCESSED ENDOSCOPIC TROCAR
K043592 · Sterilmed, Inc. · May 2005
VANGUARD REPROCESSED DILATING TIP AND BLUNT TROCARS
K043253 · Vanguard Medical Concepts, Inc. · Apr 2005