510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K082046Substantially Equivalent

Karl Storz Pediatric Flexible Cysto-Urethro-Fiberscope, Model 11278C1/acui and Circon Aur-735 Pediatric Cystouretherosco

Karl Storz Endoscopy-America, Inc., Culver City CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K082046 is the FDA 510(k) clearance record for KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI AND CIRCON AUR-735 PEDIATRIC CYSTOURETHEROSCO, a class II device, cleared for KARL STORZ Endoscopy-America, Inc. on under FDA product code FBO (Cystourethroscope). FDA records list 402 510(k) clearances for KARL STORZ Endoscopy-America, Inc., from to . As of , FDA records show one recall naming K082046.

Clearance record

Decision date
Received
(84 days to decision)
Product code
FBO Cystourethroscope
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
KARL STORZ Endoscopy-America, Inc. 600 Corporate Pt.e, Culver City CA
510(k) summary
Summary PDF
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