510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K802374Substantially Equivalent

Robertson Obturation Monitor Insuffla

Endotek Corp., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K802374 is the FDA 510(k) clearance record for ROBERTSON OBTURATION MONITOR INSUFFLA, a class II device, cleared for Endotek Corp. on under FDA product code FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic Device). FDA records list 2 510(k) clearances for Endotek Corp., from to . As of , FDA records show no recalls naming K802374.

Clearance record

Decision date
Received
(56 days to decision)
Product code
FAP Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
Regulation
21 CFR 876.1620
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Endotek Corp. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code FAP

Trailing 12 months

FDA records hold no clearances under product code FAP in the trailing twelve months.

FDA records show no clearances under product code FAP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FAP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260