FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

REUSABLE BRONCHIAL BIOPSY FORCEPS

K Number: K022398 · Decision Oct 11, 2002
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
5
Applicant Total
26
Review Days
80

Research this 510(k) in seconds

The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

Free to try · every answer cites its records

Basic Information

Device Name
REUSABLE BRONCHIAL BIOPSY FORCEPS
K Number
K022398
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
874.4680
Medical Specialty
Ear, Nose, Throat
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Ballard Medical Products
Date Received
July 23, 2002
Decision Date
October 11, 2002
Product Code
BWH
Advisory Committee
Ear, Nose, Throat
Review Advisory Committee
EN
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
BWH Forceps, Biopsy, Bronchoscope (Non-Rigid)

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (BWH), ordered by most recent decision date.

View all

Other Clearances by Ballard Medical Products

K Number Device Name
K030721 QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE
K013892 LUTZ NEEDLE
K000495 BALLARD MEDICAL PRODUCTS EPIDURAL AND SPINAL NEEDLES
K993138 BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KIT
K990376 BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME
K982894 MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT
K974630 72 HOUR USE TRACH CARE WITH MICROBAN
K964369 TRACH CARE SET WITH MICROBAN
K951533 EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT
K923487 BAL CATH
Search all 26 clearances from Ballard Medical Products →