FDA 510(k)
FDA unclassified
Substantially Equivalent
🇨🇦 Canada
GAUZE SPONGES, INTERNAL AND EXTERNAL
K Number: K905136
·
Decision Mar 6, 1991
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
270
Applicant Total
14
Review Days
111
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Basic Information
- Device Name
- GAUZE SPONGES, INTERNAL AND EXTERNAL
- K Number
- K905136
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- American Healthcare Corp.
- Date Received
- November 15, 1990
- Decision Date
- March 6, 1991
- 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 American Healthcare Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K924192 | I.V. START KIT (AHC-50-54954 | Aug 27, 1993 | Unknown |
| K923938 | IRRIGATION TRAY W/ PISTON SYRINGE & STERILE WATER | Jun 17, 1993 | Unknown |
| K923939 | IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATER | Jun 17, 1993 | Unknown |
| K923940 | IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINE | Jun 17, 1993 | Unknown |
| K923941 | IRRIGATION TRAY W/ BULB SYRINGE & STERILE SALINE | Jun 17, 1993 | Unknown |
| K924193 | TRACHEOSTOMY CARE SET W/ HYDRO PEROX(AHC-20-54685) | Jun 16, 1993 | Unknown |
| K924191 | TRACHEOSTOMY CARE SET WITH GLOVES AND EXTRA TOWEL | Apr 2, 1993 | Unknown |
| K924195 | TRACHEOSTOMY CARE SET W/FORCEPS & GAUZE TRACH DRES | Jan 6, 1993 | Substantially Equivalent |
| K924194 | TRACHEOSTOMY CARE SET W/EXTRA TOWEL(AHC-20-54686) | Jan 6, 1993 | Unknown |
| K923834 | TRACHEOSTOMY CARE SET WITH GLOVES | Dec 10, 1992 | Unknown |