Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K760274Substantially Equivalent

Tip, Rubber, Perforated

V. Mueller O.V. Baxter Healthcare Corp., Mchenry IL / Traditional, Substantially Equivalent

K760274 is the FDA 510(k) clearance record for TIP, RUBBER, PERFORATED, a class II device, cleared for V. Mueller O.V. Baxter Healthcare Corp. on under FDA product code FAJ (Cystoscope And Accessories, Flexible/Rigid). FDA's definition for product code FAJ reads: "To examine and perform procedures within the urinary tract. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807...". FDA records list 41 510(k) clearances for V. Mueller O.V. Baxter Healthcare Corp., from to . As of , FDA records show no recalls naming K760274.

Clearance record

Decision date
Received
(39 days to decision)
Product code
FAJ Cystoscope And Accessories, Flexible/Rigid
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
V. Mueller O.V. Baxter Healthcare Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FAJ

Trailing 12 months
5 clearances under product code FAJ in the twelve months to October 2026, April 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FAJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20262
May 20262
June 20260
July 20260
August 20260
September 20260
October 20260