FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
S&T SINGLE USE MICRO ANASTOMOSIS CLAMP
K Number: K022754
·
Decision Oct 16, 2002
Classifications
1
FEI Numbers
186
Registration Numbers
186
Same Product Code
203
Applicant Total
2
Review Days
58
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Basic Information
- Device Name
- S&T SINGLE USE MICRO ANASTOMOSIS CLAMP
- K Number
- K022754
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4450
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- S & T AG
- Date Received
- August 19, 2002
- Decision Date
- October 16, 2002
- Product Code
- DXC
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DXC | Clamp, Vascular | FDA class 2 | Cardiovascular |
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Other Clearances by S & T AG
| K Number | Device Name | ||
|---|---|---|---|
| K031531 | S&T MICROSURGICAL SUTURE | Sep 23, 2003 | Substantially Equivalent |