DeviceClearance

Product code FWZ— General, Plastic Surgery

'LIL MAC ACCESSORY CLAMP(TM)

Classification name
Operating Room Accessories Table Tray
Device class
Class 1
Regulation
21 CFR 878.4950
Advisory panel
General, Plastic Surgery
Total cleared
61
First cleared
Most recent

FDA classification definition

“This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.”

— U.S. Food and Drug Administration, device classification record for product code FWZ under 21 CFR 878.4950, via openFDA

Market context for product code FWZ

FDA has cleared 61 devices under product code FWZ between 1976 and 1996, filed by 34 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

last 15 years

Top applicants under product code FWZ

Adverse events under product code FWZ

product code FWZ
Malfunction
932
Other
1
Total
933

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code FWZ

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