FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
APPLIED GAUZE SPONGE 2X2X8 PLY
K Number: K844674
·
Decision Apr 1, 1985
Classifications
1
FEI Numbers
63
Registration Numbers
63
Same Product Code
270
Applicant Total
12
Review Days
122
Basic Information
- Device Name
- APPLIED GAUZE SPONGE 2X2X8 PLY
- K Number
- K844674
- 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
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FDA Unclassified
·Unknown
SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S
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FDA Unclassified
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VITOP DRESSING
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GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE
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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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|---|---|---|---|
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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 |
| K844673 | APPLIED GAUZE SPONGE 4X4X16 PLY | Apr 1, 1985 | Substantially Equivalent |
| K844675 | APPLIED GAUZE SPONGE 3X3X12 | Apr 1, 1985 | Substantially Equivalent |
| K844677 | APPLIED GAUZE SPONGE 2X2X12 | Apr 1, 1985 | Substantially Equivalent |
| K844676 | APPLIED GAUZE SPONGE 4X4X8 | Apr 1, 1985 | Substantially Equivalent |