Product code FEM— Gastroenterology, Urology
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- Classification name
- Accessories, Photographic, For Endoscope (Exclude Light Sources)
- Device class
- Class 1
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 4
- First cleared
- Most recent
Market context for product code FEM
FDA has cleared devices under product code FEM between 1979 and 1994, 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
- 1994
- 1981
- 1979
Top applicants under product code FEM
Adverse events under product code FEM
product code FEM- Malfunction
- 568
- Total
- 568
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 FEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.