FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
PLASMAKINETIC GENERATOR
K Number: K003060
·
Decision Oct 31, 2000
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
21
Review Days
29
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Basic Information
- Device Name
- PLASMAKINETIC GENERATOR
- K Number
- K003060
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Everest Medical Corp.
- Date Received
- October 2, 2000
- Decision Date
- October 31, 2000
- Product Code
- GEI
- 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Everest Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K000496 | EVERSHEARS BIPOLAR SCISSORS | Apr 24, 2000 | Substantially Equivalent |
| K993412 | BITX PROBES | Mar 31, 2000 | Substantially Equivalent |
| K994336 | BITX PROBES | Feb 8, 2000 | Substantially Equivalent |
| K971565 | BICOAG COAGULATING FORCEPS | Mar 12, 1998 | Substantially Equivalent |
| K955001 | EVERSHEARS SCISSORS, BILAP PROBES, BICOAG FORCEPS | Dec 13, 1995 | Substantially Equivalent |
| K945975 | EVERSHEARS(R) SCISSORS, BILAP(R) PROBES, BICOAG(R) FORCEPS | Dec 21, 1994 | Substantially Equivalent |
| K922509 | LAPAROSCOPIC ELECTROSURG DEVICE W/IRRIGA & ASPIRA | Oct 1, 1992 | Substantially Equivalent |
| K922246 | TUBING SET W/ IRRIGATION & ASPIRATION VALVING | Sep 2, 1992 | Substantially Equivalent |
| K920089 | MONOPOLAR COAGULATING POLYPECTOMY SNARE | Mar 31, 1992 | Substantially Equivalent |
| K911787 | MONOPOLAR SPHINCTERTOME | Jul 19, 1991 | Substantially Equivalent |