FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURGICAL STAPLING INSTRU., AUTO, SUTURE
K Number: K771177
·
Decision Oct 18, 1977
Classifications
1
FEI Numbers
86
Registration Numbers
86
Same Product Code
41
Applicant Total
218
Review Days
110
Basic Information
- Device Name
- SURGICAL STAPLING INSTRU., AUTO, SUTURE
- K Number
- K771177
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
- Date Received
- June 30, 1977
- Decision Date
- October 18, 1977
- Product Code
- GAG
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| GAG | Stapler, Surgical | FDA class 2 | General Hospital |
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|---|---|---|---|
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