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510(k) K930419

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

K930419 is an FDA 510(k) premarket notification submitted by Wiltek Medical, Inc. for the device "WILTEK BIOPSY FORCEPS". The FDA issued a decision of Substantially Equivalent on June 1, 1993. The device falls under product code BWH (Forceps, Biopsy, Bronchoscope (Non-Rigid)), a Class II device regulated under 21 CFR 874.4680. Wiltek Medical, Inc. has at least 10 other 510(k) clearances on record.

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)
  • K914882 — WILTEK BALLOON CHOLANGIOGRAPHY CATHETER (January 7, 1992)
  • K914881 — WILTEK LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER (January 7, 1992)
  • K914131 — WILTEK ELECTROCAUTERY ADAPTOR (September 25, 1991)
  • K914132 — WILTEK ELECTROCAUTERY ACTIVE CORD (September 25, 1991)
  • K912122 — CHOLANGIOGRAPHY CATHETER (September 23, 1991)
  • K912288 — WILTEK STANDARD CHOLANGIOGRAPHY CATHETER (September 23, 1991)
  • K910334 — ELECTROCAUTERY PROBE (February 21, 1991)
  • K894861 — WILTEK PAPILLOTOME (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)

FDA data resources