510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K940335Substantially Equivalent

American Catheter Poly-Snare

Intl. Medical, Inc., Fort Myers FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K940335 is the FDA 510(k) clearance record for AMERICAN CATHETER POLY-SNARE, a class II device, cleared for Intl. Medical, Inc. on under FDA product code FDI (Snare, Flexible). FDA records list 17 510(k) clearances for Intl. Medical, Inc., from to . As of , FDA records show no recalls naming K940335.

Clearance record

Decision date
Received
(177 days to decision)
Product code
FDI Snare, Flexible
Regulation
21 CFR 876.4300
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Intl. Medical, Inc. 10061 Amberwood Rd., Fort Myers FL
510(k) summary
Statement
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