Product code BWP— General, Plastic Surgery

ANOGO DISPOSABLE SHOE COVER

Classification name: Shoe And Shoe Cover, Conductive
Device class: Class 1
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Total cleared: 3
First cleared: 1981-09-11
Most recent: 1988-06-23

Market context for product code BWP

FDA has cleared 3 devices under product code BWP between 1981 and 1988, filed by 3 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

19881 clearance
19831 clearance
19811 clearance

Top applicants under product code BWP

Sudreca Surgical Dressings, Inc.1 clearance
Kimberly-Clark Corp.1 clearance
Anago, Inc.1 clearance

Recent clearances under product code BWP

K880384 — KIMBERLY-CLARK X-TRA TRACTION IMPERVIOUS BOOTKimberly-Clark Corp.·1988-06-23
K831952 — SURGICAL APPAREL SHOE COVERSSudreca Surgical Dressings, Inc.·1983-07-12
K812105 — ANOGO DISPOSABLE SHOE COVERAnago, Inc.·1981-09-11

Data sourced from openFDA. This site is unofficial and independent of the FDA.