FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO: ENSEAL PTC TISSUE SEALING DEVICE
K Number: K071728
·
Decision Jul 13, 2007
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
12
Review Days
18
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Basic Information
- Device Name
- MODIFICATION TO: ENSEAL PTC TISSUE SEALING DEVICE
- K Number
- K071728
- 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
- June 25, 2007
- Decision Date
- July 13, 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 | ||
|---|---|---|---|
| K081129 | ENSEAL POWERTIP,NSEAL-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD, ETRIO-314D,-325D,-335D,-345D, ENSEAL UNIVERSAL | Jul 28, 2008 | Substantially Equivalent |
| K072493 | ENSEAL TISSUE SEALING DEVICE | Sep 27, 2007 | Substantially Equivalent |
| K072177 | ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM | Sep 5, 2007 | Substantially Equivalent |
| K070896 | ENSEAL PTC TISSUE SEALING DEVICE | Apr 24, 2007 | Substantially Equivalent |
| K070165 | ENSEAL PTC TRIO | Jan 29, 2007 | Substantially Equivalent |
| K063097 | ENSEAL PTC TISSUE SEALING DEVICE | Oct 18, 2006 | Substantially Equivalent |
| K062949 | ENSEAL PTC TISSUE SEATING SEALING DEVICE | Oct 18, 2006 | Substantially Equivalent |
| K061526 | ENSEAL PTC TISSUE SEALING DEVICE | Jun 15, 2006 | Substantially Equivalent |
| K050671 | ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM | Apr 1, 2005 | Substantially Equivalent |
| K043008 | SURGRX ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM | Nov 17, 2004 | Substantially Equivalent |