FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AUTO SUTURE
K Number: K771589
·
Decision Dec 13, 1977
Classifications
1
FEI Numbers
270
Registration Numbers
270
Same Product Code
31
Applicant Total
2
Review Days
116
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Basic Information
- Device Name
- AUTO SUTURE
- K Number
- K771589
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- U. S. Surgical Corp.
- Date Received
- August 19, 1977
- Decision Date
- December 13, 1977
- Product Code
- GDJ
- 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 |
|---|---|---|---|
| GDJ | Clamp, Surgical, General & Plastic Surgery | FDA class 1 | General, Plastic Surgery |
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Other Clearances by U. S. Surgical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K802611 | AUTO SUTURE DISPOS., EEA SURG. STAPLER | Nov 12, 1980 | Substantially Equivalent |