FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
GAUZE ASORBABLE
K Number: K844702
·
Decision Apr 1, 1985
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
270
Applicant Total
14
Review Days
119
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Basic Information
- Device Name
- GAUZE ASORBABLE
- K Number
- K844702
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Medicon, Inc.
- Date Received
- December 3, 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
Other Clearances by Medicon, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K962087 | SERVOTRONIC EC100 SYSTEM | Apr 23, 1997 | Substantially Equivalent |
| K952168 | TITANIUM MANDIBULAR FRACTURE SYSTEM | Jun 22, 1995 | Substantially Equivalent |
| K850855 | TENS GB1001 DEVICE | Jan 9, 1986 | Substantially Equivalent |
| K850852 | INFRARAX DEVICE | Aug 21, 1985 | Substantially Equivalent |
| K844573 | ABSORBABLE GAUZE PRODUCTS | Mar 5, 1985 | Substantially Equivalent |
| K844574 | WHEELCHAIRS | Feb 21, 1985 | Substantially Equivalent |
| K844705 | SHOE COVERS | Jan 10, 1985 | Substantially Equivalent |
| K844703 | GOWNS, SURGICAL | Jan 10, 1985 | Substantially Equivalent |
| K844704 | CAPS (O.R. NURSE, SURGICAL) | Jan 10, 1985 | Substantially Equivalent |
| K840034 | VACUUM STRETCHER IMMOBILIZER | Feb 27, 1984 | Substantially Equivalent |