Atlas FDA

WILTEK BIOPSY FORCEPS

FDA 510(k) clearance K930419 · decided 1993-06-01

Clearance details

K-number
K930419
Device name
WILTEK BIOPSY FORCEPS
Applicant
Wiltek Medical, Inc.
Decision
Substantially Equivalent
Date received
1993-01-26
Decision date
1993-06-01
Days to decision
126 days
Clearance type
Traditional
Product code
BWH
Device class
2
Regulation number
874.4680
Medical specialty
Ear, Nose, Throat
Advisory committee
Ear, Nose, Throat
Location
Winston-Salem, NC, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Radial Jaw 4 Pulmonary Biopsy Forceps (K252921)Boston Scientific Corporation2025-09-26
RADIAL JAW 4 PULMONARY BIOPSY FORCEPS (K121186)Boston Scientific Corp2012-05-16
RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS; RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS WITH NE (K102336)Boston Scientific Corporation2011-01-24
REUSABLE BRONCHIAL BIOPSY FORCEPS (K022398)Ballard Medical Products2002-10-11
UNIVERSAL BY RUSH-HAMPTON ARTHROSCOPIC (K843282)Rush Hampton Industries1984-10-22

Recalls involving this device

No recalls on record reference this clearance.