FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Reprocessed Vessel Sealer
K Number: K152134
·
Decision Jan 15, 2016
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
36
Applicant Total
59
Review Days
168
Basic Information
- Device Name
- Reprocessed Vessel Sealer
- K Number
- K152134
- 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
- STERILMED, INC.
- Date Received
- July 31, 2015
- Decision Date
- January 15, 2016
- Product Code
- NUJ
- 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 |
|---|---|---|---|
| NUJ | Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed | FDA class 2 | General, Plastic Surgery |
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Other Clearances by STERILMED, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K161700 | SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters | Nov 21, 2016 | Substantially Equivalent |
| K153006 | Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter | Jun 23, 2016 | Substantially Equivalent |
| K152090 | Reprocessed Steerable Introducer | Mar 23, 2016 | Substantially Equivalent |
| K150357 | Reprocessed Electrophysiology Diagnostic Catheters | Aug 27, 2015 | Substantially Equivalent |
| K143562 | Reprocessed Cordless Ultrasonic Dissection Device | May 20, 2015 | Substantially Equivalent |
| K143260 | Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/Divider | Feb 23, 2015 | Substantially Equivalent |
| K132566 | REPROCESSED HARMONIC SHEAR | Jun 14, 2014 | Substantially Equivalent |
| K133414 | REPROCESSED CLOSURE SYSTEM | Jan 22, 2014 | Substantially Equivalent |
| K123096 | REPROCESSED VESSEL SEALER | Jan 25, 2013 | Substantially Equivalent |
| K120040 | REPROCESSED SURGICAL ELECTRIC INSTRUMENT | Oct 5, 2012 | Substantially Equivalent |