FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REPROCESSED VESSEL SEALER
K Number: K123096
·
Decision Jan 25, 2013
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
36
Applicant Total
64
Review Days
115
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Basic Information
- Device Name
- REPROCESSED VESSEL SEALER
- K Number
- K123096
- 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
- October 2, 2012
- Decision Date
- January 25, 2013
- 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 | ||
|---|---|---|---|
| K240826 | Reprocessed DECANAV Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter | Oct 11, 2024 | Substantially Equivalent |
| K190478 | Reprocessed ViewFlex Xtra ICE Catheter | Nov 14, 2019 | Substantially Equivalent |
| K190610 | Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology | Aug 15, 2019 | Substantially Equivalent |
| K182272 | Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis | Apr 15, 2019 | Substantially Equivalent |
| K161700 | SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters | Nov 21, 2016 | Substantially Equivalent |
| K161086 | Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm) | Sep 20, 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 |
| K152134 | Reprocessed Vessel Sealer | Jan 15, 2016 | Substantially Equivalent |
| K150357 | Reprocessed Electrophysiology Diagnostic Catheters | Aug 27, 2015 | Substantially Equivalent |