FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SKIN STAPLING DEVICE SC2000
K Number: K832709
·
Decision Sep 26, 1983
Classifications
1
FEI Numbers
104
Registration Numbers
104
Same Product Code
18
Applicant Total
2
Review Days
45
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Basic Information
- Device Name
- SKIN STAPLING DEVICE SC2000
- K Number
- K832709
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4760
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Prosper, Inc.
- Date Received
- August 12, 1983
- Decision Date
- September 26, 1983
- Product Code
- GDT
- 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 |
|---|---|---|---|
| GDT | Staple, Removable (Skin) | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GDT), ordered by most recent decision date.
STAPLE REMOVAL KIT
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AUTO SUTURE(R) POLYMER SKIN GRAFT STAPLER*
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Other Clearances by Prosper, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K833085 | STAPLE REMOVER SR300P | Dec 14, 1984 | Substantially Equivalent |