510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K083275Substantially Equivalent

Precision Endoscopic Infrared Coagulator; Model 5100 Single- Use Disposable Maxi-Guide Flexible Lightguide; Model 5100-2

Max Endoscopy, Inc., Macedonia OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K083275 is the FDA 510(k) clearance record for PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE- USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2, a class II device, cleared for Max Endoscopy, Inc. on under FDA product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)). FDA records list 2 510(k) clearances for Max Endoscopy, Inc., from to . As of , FDA records show no recalls naming K083275.

Clearance record

Decision date
Received
(215 days to decision)
Product code
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Regulation
21 CFR 876.4300
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Max Endoscopy, Inc. 1410 Highland Rd., Suite 6, Macedonia OH
510(k) summary
Statement
Third party review
No

Clearances, product code KNS

Trailing 12 months
4 clearances under product code KNS in the twelve months to October 2026, November 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KNS, trailing twelve months
MonthClearances
November 20252
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260