FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EN BLOC BIOPSY SYSTEM
K Number: K003190
·
Decision Jun 11, 2001
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
7
Review Days
243
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Basic Information
- Device Name
- EN BLOC BIOPSY SYSTEM
- K Number
- K003190
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neothermia Corp.
- Date Received
- October 11, 2000
- Decision Date
- June 11, 2001
- 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 Neothermia Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K041347 | MODIFICATION TO EN-BLOC BIOPSY SYSTEM | Jun 4, 2004 | Substantially Equivalent |
| K033427 | MODIFICATION TO EN-BLOC BIOPSY SYSTEM | Nov 10, 2003 | Substantially Equivalent |
| K023413 | MODIFICATION TO NEOTHERMIA'S EN-BLOC BIOPSY SYSTEM | Nov 8, 2002 | Substantially Equivalent |
| K022296 | MODIFICATION TO EN-BLOC BIOPSY SYSTEM | Jul 30, 2002 | Substantially Equivalent |
| K021577 | MODIFICATION TO EN-BLOC BIOPSY SYSTEM | May 29, 2002 | Substantially Equivalent |
| K020031 | EN-BLOC BIOPSY SYSTEM, MODELS 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-302 | Mar 27, 2002 | Substantially Equivalent |