FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REPROCESSED DYONICS ARTHROSCOPIC SHAVERS
K Number: K012611
·
Decision Nov 7, 2001
Classifications
1
FEI Numbers
386
Registration Numbers
386
Same Product Code
680
Applicant Total
11
Review Days
86
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Basic Information
- Device Name
- REPROCESSED DYONICS ARTHROSCOPIC SHAVERS
- K Number
- K012611
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.1100
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alliance Medical, Inc.
- Date Received
- August 13, 2001
- Decision Date
- November 7, 2001
- Product Code
- HRX
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| HRX | Arthroscope | FDA class 2 | Orthopedic |
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Other Clearances by Alliance Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K051438 | VANGUARD REPROCESSED COMPRESSION GARMENTS (HILL-ROM) | Apr 4, 2006 | Substantially Equivalent |
| K050518 | REPROCESSED PHACOEMUISIFICATION TIPS | Sep 23, 2005 | Substantially Equivalent |
| K030187 | REPROCESSED ELECTROPHYSIOLOGY CATHETER | Sep 24, 2003 | Substantially Equivalent |
| K021654 | REPROCESSED COMPRESSION SLEEVE | Feb 5, 2003 | Substantially Equivalent |
| K012634 | REPROCESSED EXTERNAL FIXATION DEVICE | Jun 24, 2002 | Substantially Equivalent |
| K012630 | REPROCESSED LINVATEC ARTHROSCOPIC BURS | Nov 9, 2001 | Substantially Equivalent |
| K012613 | REPROCSSED LINVATEC SHAVERS | Nov 7, 2001 | Substantially Equivalent |
| K990198 | AMIB7 | Jun 29, 1999 | Substantially Equivalent |
| K951976 | ECHO. AKHO | Jul 26, 1996 | Substantially Equivalent |
| K931091 | DISPOSABLE AMA STERILE DRAPE SHEET, CAT. NO. 5252 | Feb 3, 1994 | Substantially Equivalent |