510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K935721Substantially Equivalent

Stone Extractor

Boston Scientific Corporation, Watertown MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K935721 is the FDA 510(k) clearance record for STONE EXTRACTOR, a class II device, cleared for Boston Scientific Corp on under FDA product code FFL (Dislodger, Stone, Basket, Ureteral, Metal). FDA records list 1,110 510(k) clearances for Boston Scientific Corp, from to . As of , FDA records show no recalls naming K935721.

Clearance record

Decision date
Received
(265 days to decision)
Product code
FFL Dislodger, Stone, Basket, Ureteral, Metal
Regulation
21 CFR 876.4680
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Boston Scientific Corp 480 Pleasant St., Watertown MA
510(k) summary
Summary
Third party review
No

Clearances, product code FFL

Trailing 12 months

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

FDA records show no clearances under product code FFL in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FFL, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260