510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K941992Substantially Equivalent

Cystoscope

Surgical Technologies, Inc., Miami Lakes FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K941992 is the FDA 510(k) clearance record for CYSTOSCOPE, a class II device, cleared for Surgical Technologies, Inc. on under FDA product code FBO (Cystourethroscope). FDA records list 28 510(k) clearances for Surgical Technologies, Inc., from to . As of , FDA records show no recalls naming K941992.

Clearance record

Decision date
Received
(584 days to decision)
Product code
FBO Cystourethroscope
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Surgical Technologies, Inc. 4715 NW 157th. St.,, Miami Lakes FL
510(k) summary
Summary
Third party review
No

Clearances, product code FBO

Trailing 12 months

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

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