510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K080764Substantially Equivalent

Success Cecal Intubation Assist, Model: 4100

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

K080764 is the FDA 510(k) clearance record for SUCCESS CECAL INTUBATION ASSIST, MODEL: 4100, a class II device, cleared for Max Endoscopy, Inc. on under FDA product code ODC (Endoscope Channel Accessory). FDA's definition for product code ODC reads: "To give the endoscope channel additional or improved functionality". FDA records list 2 510(k) clearances for Max Endoscopy, Inc., from to . As of , FDA records show no recalls naming K080764.

Clearance record

Decision date
Received
(49 days to decision)
Product code
ODC Endoscope Channel Accessory
Regulation
21 CFR 876.1500
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 ODC

Trailing 12 months
1 clearance under product code ODC in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code ODC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260