510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K894869Substantially Equivalent

Wiltek Polypectomy Snare

Wiltek Medical, Inc., Winston-Salem NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894869 is the FDA 510(k) clearance record for WILTEK POLYPECTOMY SNARE, a class II device, cleared for Wiltek Medical, Inc. on under FDA product code FDI (Snare, Flexible). FDA records list 21 510(k) clearances for Wiltek Medical, Inc., from to . As of , FDA records show no recalls naming K894869.

Clearance record

Decision date
Received
(143 days to decision)
Product code
FDI Snare, Flexible
Regulation
21 CFR 876.4300
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Wiltek Medical, Inc. P.O.Box 11946, Winston-Salem NC
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