FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FAST THROW STAINLESS STEEL SURGICAL SUTURE
K Number: K030926
·
Decision Jul 21, 2003
Classifications
1
FEI Numbers
112
Registration Numbers
112
Same Product Code
175
Applicant Total
64
Review Days
119
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Basic Information
- Device Name
- FAST THROW STAINLESS STEEL SURGICAL SUTURE
- K Number
- K030926
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Advanced Surgical Products, Inc.
- Date Received
- March 24, 2003
- Decision Date
- July 21, 2003
- Product Code
- FZP
- 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 |
|---|---|---|---|
| FZP | Clip, Implantable | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
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Other Clearances by Advanced Surgical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K895800 | ADVANCED SURGICAL SOLID STATE BIPOLAR COAGULATOR | Jan 22, 1990 | Substantially Equivalent |
| K896754 | I/A HANDPIECE | Jan 11, 1990 | Substantially Equivalent |
| K896305 | MULTI-USE I/A HANDPIECE | Dec 18, 1989 | Substantially Equivalent |
| K884557 | ADVANCED SURGICAL PRODUCTS SCISSORS HANDPIECE | May 12, 1989 | Substantially Equivalent |
| K884556 | DREYER CURVED ENDOILLUMINATOR | Feb 28, 1989 | Substantially Equivalent |
| K890398 | RYAN-STYLE DIRECTED INFUSION MANIPULATOR | Feb 17, 1989 | Substantially Equivalent |
| K884347 | MODIFIED DISPOSABLE COAXIAL BIPOLAR PEN | Dec 27, 1988 | Substantially Equivalent |
| K883857 | FIBEROPTIC WIRE PICK LIGHTPIPE | Sep 29, 1988 | Substantially Equivalent |
| K883858 | FIBEROPTIC SHARP INTEGRAL PICK LIGHTPIPE | Sep 29, 1988 | Substantially Equivalent |
| K883856 | FIBEROPTIC BLUNT INTEGRAL PICK LIGHTPIPE | Sep 29, 1988 | Substantially Equivalent |