510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K954972Substantially Equivalent

Lyell Sound

Venture Management Corp., Palm Harbor FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954972 is the FDA 510(k) clearance record for LYELL SOUND, a class I device, cleared for Venture Management Corp. on under FDA product code FBS (Sound, Metal, Interconnected). FDA records list 3 510(k) clearances for Venture Management Corp., from to . As of , FDA records show no recalls naming K954972.

Clearance record

Decision date
Received
(89 days to decision)
Product code
FBS Sound, Metal, Interconnected
Regulation
21 CFR 876.4590
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Venture Management Corp. 2323 Curlew Rd., Palm Harbor FL
510(k) summary
Statement
Third party review
No

Clearances, product code FBS

Trailing 12 months

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

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