510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K930419Substantially Equivalent

Wiltek Biopsy Forceps

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

K930419 is the FDA 510(k) clearance record for WILTEK BIOPSY FORCEPS, a class II device, cleared for Wiltek Medical, Inc. on under FDA product code BWH (Forceps, Biopsy, Bronchoscope (Non-Rigid)). FDA's definition for product code BWH reads: "If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at...". FDA records list 21 510(k) clearances for Wiltek Medical, Inc., from to . As of , FDA records show no recalls naming K930419.

Clearance record

Decision date
Received
(126 days to decision)
Product code
BWH Forceps, Biopsy, Bronchoscope (Non-Rigid)
Regulation
21 CFR 874.4680
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Wiltek Medical, Inc. P.O.Box 11946, Winston-Salem NC
510(k) summary
Statement
Third party review
No

Clearances, product code BWH

Trailing 12 months

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

FDA records show no clearances under product code BWH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BWH, 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