Nursing Pad, Cohesive Gel
The Nursing Pad, Cohesive Gel (product code NXH) is a Class 1 general hospital device intended to relieve sore and cracked nipples associated with breastfeeding. Regulated under 21 CFR 880.5630, it is subject to general controls and is exempt from 510(k) premarket notification requirements, though it is not GMP-exempt. The device has no implant or life-sustaining designations.
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Basic Information
- Product Code
- NXH
- Device Class
- FDA class 1
- Regulation Number
- 880.5630
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
Definition
Intended to relieve nipples that are sore and cracked from breast feeding.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K052858 | SOOTHIES GEL PADS | Feb 09, 2006 | Substantially Equivalent | Puronxy, Inc. |
FEI Numbers
This FDA classification entry is associated with 17 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 17 registration numbers. Click on an entry to view related FDA registrations.