510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K963354Substantially Equivalent

5 Star Medical Endoscope

Five Star Medical, Inc., Charlottesville VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963354 is the FDA 510(k) clearance record for 5 STAR MEDICAL ENDOSCOPE, a class II device, cleared for Five Star Medical, Inc. on under FDA product code ODF (Mini Endoscope, Gastroenterology-Urology). FDA's definition for product code ODF reads: "To examine and perform procedures in body cavities of the GI and GU tract. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR...". FDA records list 2 510(k) clearances for Five Star Medical, Inc., from to . As of , FDA records show no recalls naming K963354.

Clearance record

Decision date
Received
(378 days to decision)
Product code
ODF Mini Endoscope, Gastroenterology-Urology
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Five Star Medical, Inc. 4767 Wren Ct., Charlottesville VA
510(k) summary
Summary
Third party review
No

Clearances, product code ODF

Trailing 12 months

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

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