510(k) K930419

WILTEK BIOPSY FORCEPS by Wiltek Medical, Inc. — Product Code BWH

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 1, 1993
Date Received: January 26, 1993
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Forceps, Biopsy, Bronchoscope (Non-Rigid)
Device Class: Class II
Regulation Number: 874.4680
Review Panel: EN
Submission Type

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 https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Wiltek Medical, Inc.

K990231 — WILTEK HOT BIOPSY FORCEPS (April 13, 1999)
K922989 — WILTEK IRRIGAITON/ASPIRATION TUBE SET (February 15, 1994)
K914881 — WILTEK LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER (January 7, 1992)
K914882 — WILTEK BALLOON CHOLANGIOGRAPHY CATHETER (January 7, 1992)
K914132 — WILTEK ELECTROCAUTERY ACTIVE CORD (September 25, 1991)
K914131 — WILTEK ELECTROCAUTERY ADAPTOR (September 25, 1991)
K912288 — WILTEK STANDARD CHOLANGIOGRAPHY CATHETER (September 23, 1991)
K912122 — CHOLANGIOGRAPHY CATHETER (September 23, 1991)
K910334 — ELECTROCAUTERY PROBE (February 21, 1991)
K894871 — WILTEK BILIARY STENT SET (December 21, 1989)

Other clearances for product code BWH

K252921 — Radial Jaw 4 Pulmonary Biopsy Forceps (September 26, 2025)
K121186 — RADIAL JAW 4 PULMONARY BIOPSY FORCEPS (May 16, 2012)
K102336 — RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS; RADIAL JAW 4 PULMONARY (January 24, 2011)
K022398 — REUSABLE BRONCHIAL BIOPSY FORCEPS (October 11, 2002)
K843282 — UNIVERSAL BY RUSH-HAMPTON ARTHROSCOPIC (October 22, 1984)