Product code ESI— Unknown
GASTROTEC
- Classification name
- Polymer, Natural-Absorbable Gelatin Material
- Device class
- Class 3
- Advisory panel
- Unknown
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code ESI
FDA has cleared devices under product code ESI between 1991 and 1996, filed by 2 applicant companies. No FDA device recalls reference this product code. Class III devices are high-risk and generally require premarket approval (PMA); 510(k) clearance under a Class III product code is limited to certain preamendments-type devices.
Clearances per year
- 1996
- 1991
Top applicants under product code ESI
Recent clearances under product code ESI
Data sourced from openFDA. This site is unofficial and independent of the FDA.