FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FERRIS POLYMEM STERILE BREAST PAD
K Number: K031660
·
Decision Feb 22, 2005
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
0
Applicant Total
20
Review Days
636
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- FERRIS POLYMEM STERILE BREAST PAD
- K Number
- K031660
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5630
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ferris Mfg. Corp.
- Date Received
- May 28, 2003
- Decision Date
- February 22, 2005
- Product Code
- NTX
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NTX | Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68) | FDA class 1 | General Hospital |
Other Clearances by Ferris Mfg. Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K031307 | FERRIS POLYMEM SILVER WOUND DRESSING | Oct 22, 2003 | Substantially Equivalent |
| K002129 | FERRIS POLYMEM STERILE WOUND DRESSING WITH COLLAGEN | Aug 25, 2000 | Substantially Equivalent |
| K991729 | FERRIS POLYOSTOMY STERILE WOUND DRESSING | Aug 27, 1999 | Substantially Equivalent |
| K990906 | FERRIS POLYMEM POLYWIC STERILE CAVITY WOUND FILLER | Apr 29, 1999 | Substantially Equivalent for Some Indications |
| K984539 | FERRIS POLYMEM CALCIUM ALGINATE STERILE WOUND DRESSING | Mar 1, 1999 | Substantially Equivalent |
| K982306 | POLYTUBE | Sep 22, 1998 | Substantially Equivalent |
| K932913 | FERRIS POLYMEM HYDROPHILIC WOUND DRESSING | Jun 7, 1994 | Substantially Equivalent for Some Indications |
| K900127 | FERRIS HYDROPHILIC DRESSING (ADD'L INDICATIONS) | May 18, 1990 | Substantially Equivalent for Some Indications |
| K880330 | FERRIS HYDROPHILIC DRESSING | Mar 23, 1988 | Substantially Equivalent for Some Indications |
| K874478 | DYNAFILM | Jan 14, 1988 | Substantially Equivalent for Some Indications |