FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT
K Number: K131709
·
Decision Oct 4, 2013
Classifications
1
FEI Numbers
227
Registration Numbers
227
Same Product Code
64
Applicant Total
112
Review Days
115
Basic Information
- Device Name
- SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT
- K Number
- K131709
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 874.4420
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ARTHROCARE CORP.
- Date Received
- June 11, 2013
- Decision Date
- October 4, 2013
- Product Code
- LRC
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| LRC | Instrument, Ent Manual Surgical | FDA class 1 | Ear, Nose, Throat |
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|---|---|---|---|
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| K111397 | TITAN TI SUTURE ANCHOR SYSTEM | Jul 12, 2011 | Substantially Equivalent |
| K110781 | 5.5 / 6.5MM SPARTAN PEEK SURTURE IMPLANT WITH #2 MAGNUMWIRE / WITH NEEDLES, EXTRACTION TOOL, 5.5 / 6.5MM PUNCH TAP | May 27, 2011 | Substantially Equivalent |
| K110183 | ARTHROCARE PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE | Feb 16, 2011 | Substantially Equivalent |
| K110164 | 5.5MM SPARTAN PEEK SUTURE IMPLANT W/ #2 MAGNUM WIRE, PUNCH TAP, EXTRACTION TOOL | Feb 7, 2011 | Substantially Equivalent |
| K101437 | SPEEDFIX SUTURE SYSTEM | Oct 29, 2010 | Substantially Equivalent |
| K102262 | ARTHOCARE SPARTAN PEEK SUTURE IMPLANT SYSTEM; PUNCH TAP ; EXTRACTION TOOL | Oct 21, 2010 | Substantially Equivalent |
| K100479 | PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE | Sep 21, 2010 | Substantially Equivalent |