FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
DYONICS ARTHROSCOPIC KIT
K Number: K920267
·
Decision Mar 23, 1993
Classifications
1
FEI Numbers
159
Registration Numbers
159
Same Product Code
109
Applicant Total
22
Review Days
427
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Basic Information
- Device Name
- DYONICS ARTHROSCOPIC KIT
- K Number
- K920267
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Smith & Nephew Dyonics, Inc.
- Date Received
- January 21, 1992
- Decision Date
- March 23, 1993
- Product Code
- LRO
- 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 |
|---|---|---|---|
| LRO | General Surgery Tray | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Smith & Nephew Dyonics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K955914 | LIMITED REUSE ARTHROSCOPIC BLADES | Feb 8, 1996 | Substantially Equivalent |
| K954627 | ECTRA II LIGAMENT RELEASE SYSTEM | Dec 18, 1995 | Substantially Equivalent for Some Indications |
| K954989 | DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES | Nov 27, 1995 | Substantially Equivalent |
| K953695 | DYONICS DISPOSABLE ARTHROSCOPIC BLADES | Sep 15, 1995 | Substantially Equivalent |
| K953387 | ECTRA LIGAMENT RELEASE SYSTEM | Aug 9, 1995 | Substantially Equivalent |
| K945182 | DYONICS FIXATION SCREWS | Jan 24, 1995 | Substantially Equivalent for Some Indications |
| K936071 | SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE | Aug 19, 1994 | Substantially Equivalent |
| K934299 | DYONICS DISPOSABLE ARTHROSCOPIC SURGERY BLADES MODIFICATION | Feb 14, 1994 | Substantially Equivalent |
| K922176 | INTELIJET SUCTION SUPPLY | Nov 18, 1992 | Substantially Equivalent |
| K914963 | SMITH & NEPHEW DYONICS TMJ ARTHROSCOPY INFLOW SET | Jun 4, 1992 | Substantially Equivalent |