510(k) K022398

REUSABLE BRONCHIAL BIOPSY FORCEPS by Ballard Medical Products — Product Code BWH

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 11, 2002
Date Received: July 23, 2002
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 Ballard Medical Products

K030721 — QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE (March 31, 2003)
K013892 — LUTZ NEEDLE (July 11, 2002)
K000495 — BALLARD MEDICAL PRODUCTS EPIDURAL AND SPINAL NEEDLES (March 28, 2000)
K993138 — BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KIT (October 20, 1999)
K990376 — BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME (May 3, 1999)
K982894 — MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT (September 11, 1998)
K974630 — 72 HOUR USE TRACH CARE WITH MICROBAN (March 11, 1998)
K964369 — TRACH CARE SET WITH MICROBAN (February 11, 1997)
K951533 — EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT (July 5, 1995)
K923487 — BAL CATH (July 30, 1993)

510(k) K022398

Clearance Details

Device Classification

Other clearances by Ballard Medical Products

Other clearances for product code BWH