FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
APPLIED GAUZE SPONGE 4X4X16 PLY
K Number: K844673
·
Decision Apr 1, 1985
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
270
Applicant Total
14
Review Days
122
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Basic Information
- Device Name
- APPLIED GAUZE SPONGE 4X4X16 PLY
- K Number
- K844673
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Applied Medical
- Date Received
- November 30, 1984
- Decision Date
- April 1, 1985
- 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
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| K003443 | SUCTION IRRIGATOR | Feb 1, 2001 | Substantially Equivalent |
| K002915 | FLEXIBLE OCCLUSION SYSTEM | Jan 8, 2001 | Substantially Equivalent |
| K915826 | BIO-POLAR FORCEPS | Jun 2, 1992 | Substantially Equivalent |
| K911462 | SURGICAL TROCAR | Apr 22, 1991 | Substantially Equivalent |
| K844677 | APPLIED GAUZE SPONGE 2X2X12 | Apr 1, 1985 | Substantially Equivalent |
| K844674 | APPLIED GAUZE SPONGE 2X2X8 PLY | Apr 1, 1985 | Substantially Equivalent |