DeviceClearance

Product code GBW— General, Plastic Surgery

ADT MINI PERITONEAL LAVAGE KIT

Classification name
Catheter, Peritoneal
Device class
Class 1
Regulation
21 CFR 878.4200
Advisory panel
General, Plastic Surgery
Total cleared
17
First cleared
Most recent

Market context for product code GBW

FDA has cleared 17 devices under product code GBW between 1980 and 1999, filed by 12 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

Top applicants under product code GBW

Adverse events under product code GBW

product code GBW
Death
6
Total
6

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 GBW

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