Cleared Traditional

K083275 - PRECISION ENDOSCOPIC INFRARED COAGULATOR

Also marketed or referenced as:
MODEL 5100 SINGLE- USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE MODEL 5100-2

K083275 is an FDA 510(k) clearance for PRECISION ENDOSCOPIC INFRARED COAGULATOR, manufactured by Max Endoscopy, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNS cleared through the Traditional 510(k) pathway after a 215-day FDA review.

K083275 · Max Endoscopy, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
215d
Days
Class 2
Risk

K083275 is an FDA 510(k) clearance for the PRECISION ENDOSCOPIC INFRARED COAGULATOR. Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by Max Endoscopy, Inc. (Macedonia, US). The FDA issued a Cleared decision on June 9, 2009 after a review of 215 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4300 - 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 Max Endoscopy, Inc. devices

FDA 510(k) Submission Details - K083275

510(k) Number K083275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2008
Decision Date June 09, 2009
Days to Decision 215 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 130d · This submission: 215d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNS Device Classification - Class 2, Special Controls

Product Code KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4300
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 - KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

All 116
Devices cleared under the same product code (KNS) and FDA review panel - the closest regulatory comparables to K083275.
MERIT BIPOLAR COAGULATION PROBE
K102273 · Merit Medical Systems, Inc. · Sep 2010
PROSTIVA RF THERAPY MODEL 8929 HAND PIECE
K101139 · Medtronic, Inc. · May 2010
SINGLE USE ELECTROSURGICAL KNIFE SERIES, MODEL KD-610L, KD-611L, KD-620LR, KD-630L, KF-640L
K092309 · Olympus Medical Systems Corporation · Oct 2009
PROSTIVA RF THERAPY HAND PIECE, MODEL 8929
K082464 · Medtronic, Inc. · Oct 2008
TUNA SYSTEM, MODELS 8909, 8929, 8930, 8934
K052413 · Medtronic Vascular · Nov 2005
OMNI SPHINCTEROTOME
K052051 · Wilson-Cook Medical, Inc. · Aug 2005