510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K972119Substantially Equivalent

Maloney Bouge (1210-Xx)/hurst Bougie (1212-Xx)

Medovations, Inc., Germantown WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K972119 is the FDA 510(k) clearance record for MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX), a class II device, cleared for Medovations, Inc. on under FDA product code FAT (Bougie, Esophageal, And Gastrointestinal, Gastro-Urology). FDA records list 31 510(k) clearances for Medovations, Inc., from to . As of , FDA records show no recalls naming K972119.

Clearance record

Decision date
Received
(242 days to decision)
Product code
FAT Bougie, Esophageal, And Gastrointestinal, Gastro-Urology
Regulation
21 CFR 876.5365
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Medovations, Inc. W194 N11340 Mccormick Dr., Germantown WI
510(k) summary
Statement
Third party review
No

Clearances, product code FAT

Trailing 12 months

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

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