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
NXHClass I

Nursing Pad, Cohesive Gel

21 CFR 880.5630 / General Hospital
FDA source (opens on fda.gov)

NXH is the FDA product code for Nursing Pad, Cohesive Gel, a class I device type, regulated under 21 CFR 880.5630. FDA's definition for this code reads: "Intended to relieve nipples that are sore and cracked from breast feeding". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
NXH
Device name
Nursing Pad, Cohesive Gel
FDA definition
Intended to relieve nipples that are sore and cracked from breast feeding.
Regulation
21 CFR 880.5630
Device class
Class I
Review panel
General Hospital
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code NXH

By decision year
1 clearance under product code NXH with a decision year between 2006 and 2006, 2006 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NXH by decision year
YearClearances
20061

Applicants with the most clearances

Product code NXH
Applicants holding the most 510(k) clearances under product code NXH
ApplicantClearances
Puronxy, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 19 companies shown, in name order