FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARTELON SURGICAL SUTURE
K Number: K052482
·
Decision Oct 17, 2005
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
56
Applicant Total
7
Review Days
38
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Basic Information
- Device Name
- ARTELON SURGICAL SUTURE
- K Number
- K052482
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.5020
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Artimplant AB
- Date Received
- September 9, 2005
- Decision Date
- October 17, 2005
- Product Code
- GAR
- 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 |
|---|---|---|---|
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
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Other Clearances by Artimplant AB
| K Number | Device Name | ||
|---|---|---|---|
| K071887 | SPORTMESH OR ARTELON TISSUE REINFORCEMENT | Sep 18, 2007 | Substantially Equivalent |
| K061956 | ARTELON STT SPACER | Jun 7, 2007 | Substantially Equivalent |
| K061954 | ARTELON CMC SPACER ARTHRO | Jun 1, 2007 | Substantially Equivalent |
| K052830 | SPORTMESH | Jan 19, 2006 | Substantially Equivalent |
| K040070 | ARTELON SPACER CMC-1 | Sep 21, 2004 | Substantially Equivalent |
| K032160 | ARTELON SURGICAL SUTURE | Nov 17, 2003 | Substantially Equivalent |