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
PIFClass II

Gastrointestinal Tubes With Enteral Specific Connectors

21 CFR 876.5980 / Gastroenterology, Urology
FDA source (opens on fda.gov)

PIF is the FDA product code for Gastrointestinal Tubes With Enteral Specific Connectors, a class II device type, regulated under 21 CFR 876.5980. FDA's definition for this code reads: "To facilitate enteral specific connections". As of , FDA records hold 51 510(k) clearances under this code, the most recent dated , and 112 recalls.

Classification record

Product code
PIF
Device name
Gastrointestinal Tubes With Enteral Specific Connectors
FDA definition
To facilitate enteral specific connections.
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
52
Ingested recalls
112

Clearances, product code PIF

By decision year
52 clearances under product code PIF with a decision year between 2014 and 2026, 2015 the highest year at 9.
Show the numbers
510(k) clearances under FDA product code PIF by decision year
YearClearances
20143
20159
20163
20175
20182
20197
20204
20214
20224
20234
20242
20252
20263

Applicants with the most clearances

Product code PIF
Applicants holding the most 510(k) clearances under product code PIF
ApplicantClearances
Medtronic, Inc.3
MEDLINE INDUSTRIES, LP - Northfield3
Vesco Medical LLC3
Boston Scientific Corporation2
Cair LGL2
Cardinalhealth2
Cedic S.r.l.2
Degania Silicone, Inc.2
Rockfield Medical2
Syncro Medical Innovations, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 79 companies shown, in name order