510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K904793Substantially Equivalent

Surgitek Graduated Ureteroscope (Model Gu-8)

Surgitek, Racine WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904793 is the FDA 510(k) clearance record for SURGITEK GRADUATED URETEROSCOPE (MODEL GU-8), a class II device, cleared for Surgitek on under FDA product code FGB (Ureteroscope And Accessories, Flexible/Rigid). FDA's definition for product code FGB reads: "To perform various diagnostic and therapeutic procedures within the urinary tract. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k)...". FDA records list 29 510(k) clearances for Surgitek, from to . As of , FDA records show no recalls naming K904793.

Clearance record

Decision date
Received
(133 days to decision)
Product code
FGB Ureteroscope And Accessories, Flexible/Rigid
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Surgitek 3037 Mt. Pleasant St., Racine WI
Third party review
No

Clearances, product code FGB

Trailing 12 months
11 clearances under product code FGB in the twelve months to October 2026, August 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code FGB, trailing twelve months
MonthClearances
November 20251
December 20252
January 20260
February 20260
March 20261
April 20261
May 20260
June 20260
July 20261
August 20263
September 20262
October 20260