FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL
K Number: K002484
·
Decision Oct 4, 2000
Classifications
1
FEI Numbers
36
Registration Numbers
37
Same Product Code
22
Applicant Total
9
Review Days
51
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Basic Information
- Device Name
- EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL
- K Number
- K002484
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.4580
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Electro Medical Systems SA
- Date Received
- August 14, 2000
- Decision Date
- October 4, 2000
- Product Code
- JDX
- 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 |
|---|---|---|---|
| JDX | Instrument, Surgical, Sonic And Accessory/Attachment | FDA class 2 | Orthopedic |
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Other Clearances by Electro Medical Systems SA
| K Number | Device Name | ||
|---|---|---|---|
| K022328 | EMS PIEZON MASTER 600 | Aug 13, 2002 | Substantially Equivalent |
| K022119 | EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE | Jul 25, 2002 | Substantially Equivalent |
| K012445 | EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA) | Aug 24, 2001 | Substantially Equivalent |
| K992251 | SWISS LITHOCLAST MULTIPURPOSE PROBE | Jul 27, 1999 | Substantially Equivalent |
| K963285 | EMS SWISS LITHOCLAST LITHOTRIPTER | Feb 13, 1997 | Substantially Equivalent |
| K964111 | LITHOVAC SUCTION/ASPIRATION PROBE | Dec 16, 1996 | Substantially Equivalent |
| K953026 | MINIPIEZON | Aug 28, 1995 | Substantially Equivalent |
| K951531 | SWISS LITHOCLAST LITHOTRIPTER | Aug 24, 1995 | Substantially Equivalent |