FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
LAPAROTOMY SPONGES
K Number: K905135
·
Decision Mar 6, 1991
Classifications
1
FEI Numbers
211
Registration Numbers
211
Same Product Code
110
Applicant Total
14
Review Days
111
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Basic Information
- Device Name
- LAPAROTOMY SPONGES
- K Number
- K905135
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4450
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- American Healthcare Corp.
- Date Received
- November 15, 1990
- Decision Date
- March 6, 1991
- Product Code
- GDY
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GDY), ordered by most recent decision date.
ULTRACELL SUCTION SPONGE
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CPR LAP SPONGES
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STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE
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FDA Class 1
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PROTEC X-RAY DETECTABLE GAUZE SPONGE
FDA 510(k)
FDA Class 1
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KENSORB
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
TRIANGULAR SPONGES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
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 |