510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
FIHClass II

Pump, Infusion Or Syringe, Extra-Luminal

21 CFR 876.5820 / Gastroenterology, Urology
FDA source (opens on fda.gov)

FIH is the FDA product code for Pump, Infusion Or Syringe, Extra-Luminal, a class II device type, regulated under 21 CFR 876.5820. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FIH
Device name
Pump, Infusion Or Syringe, Extra-Luminal
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
5
Ingested recalls
0

Clearances, product code FIH

By decision year
5 clearances under product code FIH with a decision year between 1988 and 1995, 1994 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code FIH by decision year
YearClearances
19881
19901
19942
19951

Applicants with the most clearances

Product code FIH
Applicants holding the most 510(k) clearances under product code FIH
ApplicantClearances
B&B Medical Assoc., Inc.1
E-Z-EM, Inc1
Infusion Technology Intl.1
L H M Ent., Inc.1
Pharmacia Deltec, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code