510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K061646Substantially Equivalent

Laserscope Guided Delivery Device (Gdd) Cystourethroscope & Accessories

Laserscope, San Jose CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061646 is the FDA 510(k) clearance record for LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES, a class II device, cleared for Laserscope on under FDA product code FBO (Cystourethroscope). FDA records list 60 510(k) clearances for Laserscope, from to . As of , FDA records show no recalls naming K061646.

Clearance record

Decision date
Received
(15 days to decision)
Product code
FBO Cystourethroscope
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Laserscope 3070 Orchard Dr., San Jose CA
510(k) summary
Summary PDF
Third party review
Yes

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