Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm)— 510(k) K161086
Substantially EquivalentSterilmed, Inc.
FDA 510(k) clearance K161086 for Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm), Substantially Equivalent on 2016-09-20. Applicant: Sterilmed, Inc.. Device class: 2.
Clearance details
- Applicant
- Sterilmed, Inc.
- Product code
- Code NUJ
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plymouth, MN, US
Recent devices under product code NUJ
view all- K232511 — Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)
- K230251 — Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)
- K220411 — Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)
- K211203 — Green OR Reprocessed Aquamantys Bipolar Sealer
- K191073 — Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter
More clearances from Sterilmed, Inc.
view all- K254149 — Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825) +3 more
- K240826 — Reprocessed DECANAV Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter
- K190478 — Reprocessed ViewFlex Xtra ICE Catheter
- K190610 — Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology
- K182272 — Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis
Data sourced from openFDA. This site is unofficial and independent of the FDA.