FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CHRISTOUDIAS SLIM TIP ELECTRODE INSERT
K Number: K992345
·
Decision Sep 10, 1999
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
6
Review Days
89
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Basic Information
- Device Name
- CHRISTOUDIAS SLIM TIP ELECTRODE INSERT
- K Number
- K992345
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Innervision, Inc.
- Date Received
- June 13, 1999
- Decision Date
- September 10, 1999
- 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 Innervision, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K991877 | MACMED PAEDIATRIC INTRAMEDULLARY NAIL | Aug 6, 1999 | Substantially Equivalent |
| K982428 | CHRISTOUDIAS GAUZE DISSECTOR (LAPAROSCOPIC HAND INSTRUMENT) | Oct 9, 1998 | Substantially Equivalent |
| K940731 | INNERVISION INC. CANNULA/TROCAR,MULTIPLE TYPES | Sep 13, 1994 | Substantially Equivalent |
| K940750 | INNERVISION,INC. LAPAROSCOPIC ELECTRODES | Aug 23, 1994 | Substantially Equivalent |
| K940718 | INNERVISION INC. LAPAROSCOPIC HAND INSTRUMENTS | Jul 22, 1994 | Substantially Equivalent |