FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ETHICON ENDO-SURGERY ENSEAL G2 CORDLESS TISSUE SEALERS
K Number: K123212
·
Decision Mar 8, 2013
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
39
Review Days
144
Basic Information
- Device Name
- ETHICON ENDO-SURGERY ENSEAL G2 CORDLESS TISSUE SEALERS
- K Number
- K123212
- 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
- ETHICON ENDO-SURGERY, LLC
- Date Received
- October 15, 2012
- Decision Date
- March 8, 2013
- Product Code
- PDG
- 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 |
|---|---|---|---|
| PDG | Electrosurgical Vessel And/Or Tissue Sealer. With Built-In Generator. | FDA class 2 | General, Plastic Surgery |
Other Clearances by ETHICON ENDO-SURGERY, LLC
| K Number | Device Name | ||
|---|---|---|---|
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| K160554 | Enseal X1 Large Jaw Tissue Sealer | Sep 9, 2016 | Substantially Equivalent |
| K160521 | ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mm | Mar 22, 2016 | Substantially Equivalent |
| K151136 | HARMONIC HOOK | Mar 4, 2016 | Substantially Equivalent |
| K150840 | Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip Applier | Sep 10, 2015 | Substantially Equivalent |
| K151340 | HARMONIC Focus Long Shears + Adaptive Tissue Technology | Jul 10, 2015 | Substantially Equivalent |
| K141122 | HARMONIC SCALLOP BLADE, GENERATOR G11 | Sep 15, 2014 | Substantially Equivalent |
| K140560 | ECHELON FLEX POWERED PLUS ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60MM, STANDARD, ECHELON FLEX POWERED PLUS ARTICULATING | Apr 22, 2014 | Substantially Equivalent |
| K132522 | HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE | Dec 16, 2013 | Substantially Equivalent |
| K133314 | HARMONIC FOCUS SHEARS + ADAPTIVE TISSUE TECHNOLOGY | Dec 3, 2013 | Substantially Equivalent |