FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENSEAL TISSUE SEALING DEVICE
K Number: K072493
·
Decision Sep 27, 2007
Classifications
1
FEI Numbers
839
Registration Numbers
839
Same Product Code
2251
Applicant Total
4
Review Days
22
Basic Information
- Device Name
- ENSEAL TISSUE SEALING DEVICE
- K Number
- K072493
- 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
- SURGRX INC
- Date Received
- September 5, 2007
- Decision Date
- September 27, 2007
- 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 SURGRX INC
| K Number | Device Name | ||
|---|---|---|---|
| K062949 | ENSEAL PTC TISSUE SEATING SEALING DEVICE | Oct 18, 2006 | Substantially Equivalent |
| K061526 | ENSEAL PTC TISSUE SEALING DEVICE | Jun 15, 2006 | Substantially Equivalent |
| K031133 | SURGRX ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM INCLUDING THE ENSEAL CONTROLLER ADAPTER, ENSEAL OPEN AND LAPAROSCOPIS | Jul 3, 2003 | Substantially Equivalent |