510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K133987Substantially Equivalent

Captivator Ii,single-Use Polypectomy Snares

Boston Scientific Corporation, Marlboro MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K133987 is the FDA 510(k) clearance record for CAPTIVATOR II,SINGLE-USE POLYPECTOMY SNARES, a class II device, cleared for Boston Scientific Corporation on under FDA product code FDI (Snare, Flexible). FDA records list 1,110 510(k) clearances for Boston Scientific Corporation, from to . As of , FDA records show one recall naming K133987.

Clearance record

Decision date
Received
(29 days to decision)
Product code
FDI Snare, Flexible
Regulation
21 CFR 876.4300
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Boston Scientific Corporation 100 Boston Scientific Way, Marlboro MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FDI

Trailing 12 months
1 clearance under product code FDI in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FDI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260