510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K760273Substantially Equivalent

Lithotrite

V. Mueller O.V. Baxter Healthcare Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K760273 is the FDA 510(k) clearance record for LITHOTRITE, a class II device, cleared for V. Mueller O.V. Baxter Healthcare Corp. on under FDA product code FGK (Tripsor, Stone, Bladder). 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 K760273.

Clearance record

Decision date
Received
(137 days to decision)
Product code
FGK Tripsor, Stone, Bladder
Regulation
21 CFR 876.4500
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 FGK

Trailing 12 months

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

FDA records show no clearances under product code FGK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FGK, 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