FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
GAUZE SPONGES USP TYPE VII
K Number: K861215
·
Decision Apr 17, 1986
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
270
Applicant Total
7
Review Days
17
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Basic Information
- Device Name
- GAUZE SPONGES USP TYPE VII
- K Number
- K861215
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Selomas, Inc.
- Date Received
- March 31, 1986
- Decision Date
- April 17, 1986
- Product Code
- EFQ
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| EFQ | Gauze/Sponge, Internal | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EFQ), ordered by most recent decision date.
NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE
FDA 510(k)
FDA Unclassified
·Unknown
SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S
FDA 510(k)
FDA Unclassified
·Unknown
VITOP DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE
FDA 510(k)
FDA Unclassified
·Unknown
CROSSTEX NON-WOVEN SPONGES
FDA 510(k)
FDA Unclassified
·Unknown
GAUZE, SPONGES, CAT # 11-003
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Selomas, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K821258 | SELOPOR | Aug 19, 1982 | Substantially Equivalent |
| K821260 | VITOFIT | Jun 23, 1982 | Substantially Equivalent |
| K821259 | VITASAN | Jun 23, 1982 | Substantially Equivalent |
| K821490 | SILKAFIX ADHESIVE PLASTER | Jun 2, 1982 | Substantially Equivalent |
| K821257 | SELOFIX | May 14, 1982 | Substantially Equivalent |
| K812501 | OPRAFLEX | Oct 2, 1981 | Substantially Equivalent |