FIH — Pump, Infusion Or Syringe, Extra-Luminal Class II
FDA product code FIH covers "Pump, Infusion Or Syringe, Extra-Luminal", a Class II medical device regulated under 21 CFR 876.5820. Submissions are reviewed by the Gastroenterology, Urology panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FIH
- Device Class
- Class II
- Regulation Number
- 876.5820
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K932055 | e-z-em | PERCUPUMP II | March 21, 1995 |
| K931113 | pharmacia deltec | CADD-TPN(TM) AMBULATORY INFUSION SYSTEM | April 28, 1994 |
| K935461 | infusion technology intl | VECTOR AMBULATORY DRUG DELIVERY SYSTEM | April 28, 1994 |
| K900439 | l h m ent | SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CC | February 15, 1990 |
| K881707 | b and b medical assoc | INTROCULAR FLUID INJECTOR | October 21, 1988 |