FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
XCLOSE TISSUE REPAIR SYSTEM, MODEL SRS
K Number: K062307
·
Decision Sep 1, 2006
Classifications
1
FEI Numbers
233
Registration Numbers
233
Same Product Code
166
Applicant Total
12
Review Days
24
Basic Information
- Device Name
- XCLOSE TISSUE REPAIR SYSTEM, MODEL SRS
- K Number
- K062307
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.5000
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ANULEX TECHNOLOGIES, INC
- Date Received
- August 8, 2006
- Decision Date
- September 1, 2006
- Product Code
- GAT
- 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 |
|---|---|---|---|
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | FDA class 2 | General, Plastic Surgery |
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Other Clearances by ANULEX TECHNOLOGIES, INC
| K Number | Device Name | ||
|---|---|---|---|
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| K121354 | MICRO/MINI N-PK(F) BONE ANCHOR | Nov 9, 2012 | Substantially Equivalent |
| K113805 | FIXATE TISSUE BAND | Feb 23, 2012 | Substantially Equivalent |
| K113400 | FIXATE TISSUE BAND | Dec 16, 2011 | Substantially Equivalent |
| K112849 | FIXATE TISSUE BAND | Oct 27, 2011 | Substantially Equivalent |
| K111462 | FIXATE TISSUE BAND | Sep 8, 2011 | Substantially Equivalent |
| K100572 | VERSACLOSE, MODEL VC-200-01 | Mar 17, 2010 | Substantially Equivalent |
| K091432 | XCLOSE TISSUE REPAIR SYSTEM, MODEL XC-200-01 | Jun 12, 2009 | Substantially Equivalent |
| K082729 | RIMCLOSE BONE ANCHOR | Dec 19, 2008 | Substantially Equivalent |
| K061386 | ANCHOR BAND SUTURING SYSTEM, MODEL SR-AB | Jul 5, 2006 | Substantially Equivalent |