FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELECTRO-LUBE
K Number: K033880
·
Decision Mar 10, 2004
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
9
Review Days
86
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Basic Information
- Device Name
- ELECTRO-LUBE
- K Number
- K033880
- 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
- Mectra Labs, Inc.
- Date Received
- December 15, 2003
- Decision Date
- March 10, 2004
- 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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| K934547 | MECTRA TROCAR | Feb 18, 1994 | Substantially Equivalent |
| K935382 | GRASPERS | Feb 15, 1994 | Substantially Equivalent |
| K925691 | INSUFFLATION TUBING | Sep 23, 1993 | Substantially Equivalent |
| K920959 | INSUFFLATOR, LAPAROSCOPIC | Jul 13, 1992 | Substantially Equivalent |