FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SUPERSTITCH VASCULAR SUTURING DEVICE, 6 FRENCH, MODELS 06-15-00X; MID-LENGTH 06-25-00X
K Number: K020940
·
Decision Apr 17, 2002
Classifications
1
FEI Numbers
108
Registration Numbers
108
Same Product Code
84
Applicant Total
5
Review Days
26
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Basic Information
- Device Name
- SUPERSTITCH VASCULAR SUTURING DEVICE, 6 FRENCH, MODELS 06-15-00X; MID-LENGTH 06-25-00X
- K Number
- K020940
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.5010
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sutura, Inc.
- Date Received
- March 22, 2002
- Decision Date
- April 17, 2002
- Product Code
- GAW
- 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 |
|---|---|---|---|
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Sutura, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K062125 | SUPERSTITCH 5F, 12F, AND EL | Oct 19, 2006 | Substantially Equivalent |
| K053482 | SUPERSTITCH GW, MODELS 06-15-04-GW, 08-15-04-GW | Dec 27, 2005 | Substantially Equivalent |
| K012865 | SUPERSTITCH VASCULAR SUTURING DEVICE | Sep 25, 2001 | Substantially Equivalent |
| K994087 | SUPERSTITCH | Mar 1, 2000 | Substantially Equivalent |