FDA 510(k)
FDA class 1
Substantially Equivalent for Some Indications
🇺🇸 United States
NON-ABSORBABLE GAUZE, SURGICAL SPONGE & DRESSING
K Number: K891101
·
Decision Apr 17, 1989
Classifications
1
FEI Numbers
570
Registration Numbers
570
Same Product Code
87
Applicant Total
34
Review Days
46
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Basic Information
- Device Name
- NON-ABSORBABLE GAUZE, SURGICAL SPONGE & DRESSING
- K Number
- K891101
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4014
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Smith & Nephew United, Inc.
- Date Received
- March 2, 1989
- Decision Date
- April 17, 1989
- Product Code
- NAB
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| NAB | Gauze / Sponge,Nonresorbable For External Use | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Smith & Nephew United, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K963096 | ALLEVYN HYDRO POLY DRESSING ND ALL TRAC DRESSING | Oct 25, 1996 | Substantially Equivalent |
| K961775 | PROFORE FOUR-LAYER BANDAGE SYSTEM KIT | Jul 16, 1996 | Substantially Equivalent |
| K945330 | ALLEVYN ADHESIVE | Feb 9, 1995 | Substantially Equivalent for Some Indications |
| K943619 | CAVI-CARE CONFORMING FOAM DRESSING | Aug 19, 1994 | Substantially Equivalent for Some Indications |
| K942748 | INTRASITE | Jun 29, 1994 | Substantially Equivalent for Some Indications |
| K935705 | ALLEVYN ISLAND WOUND DRESSING | Feb 15, 1994 | Substantially Equivalent |
| K935803 | CICA-CARE SILICONE GEL SHEET | Feb 3, 1994 | Substantially Equivalent |
| K932263 | SOLOSITE DERMAL WOUND GEL | Oct 1, 1993 | Substantially Equivalent |
| K926508 | INTRASITE GEL | Jul 13, 1993 | Substantially Equivalent |
| K922897 | STRAPPAL | Sep 15, 1992 | Substantially Equivalent |