FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MICROVASIVE INSURG LAPTIE SUTURE LIGATOR
K Number: K931379
·
Decision Jul 13, 1993
Classifications
1
FEI Numbers
166
Registration Numbers
166
Same Product Code
4
Applicant Total
432
Review Days
117
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Basic Information
- Device Name
- MICROVASIVE INSURG LAPTIE SUTURE LIGATOR
- K Number
- K931379
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boston Scientific Corp
- Date Received
- March 18, 1993
- Decision Date
- July 13, 1993
- Product Code
- HCF
- 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 |
|---|---|---|---|
| HCF | Instrument, Ligature Passing And Knot Tying | FDA class 1 | General, Plastic Surgery |
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