510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K972979Substantially Equivalent

Smith & Nephew Images Cystourethroscopes and Accessories, Smith & Nephew Semi0rigid and Flexible Manual Surgical Instrum

Smith & Nephew, Inc., Andover MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K972979 is the FDA 510(k) clearance record for SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RIGID AND FLEXIBLE MANUAL SURGICAL INSTRUM, a class II device, cleared for Smith & Nephew, Inc. on under FDA product code FBO (Cystourethroscope). FDA records list 572 510(k) clearances for Smith & Nephew, Inc., from to . As of , FDA records show no recalls naming K972979.

Clearance record

Decision date
Received
(122 days to decision)
Product code
FBO Cystourethroscope
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Smith & Nephew, Inc. 160 Dascomb Rd., Andover MA
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