510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K945209Substantially Equivalent

Proctoscopea & Accessories, Sigmoidoscopes & Accessories, Proctology Instruments

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

K945209 is the FDA 510(k) clearance record for PROCTOSCOPEA & ACCESSORIES, SIGMOIDOSCOPES & ACCESSORIES, PROCTOLOGY INSTRUMENTS, a class II device, cleared for KARL STORZ Endoscopy-America, Inc. on under FDA product code GCF (Proctoscope). FDA records list 402 510(k) clearances for KARL STORZ Endoscopy-America, Inc., from to . As of , FDA records show one recall naming K945209.

Clearance record

Decision date
Received
(132 days to decision)
Product code
GCF Proctoscope
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
Third party review
No

Clearances, product code GCF

Trailing 12 months

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

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