REPROCESSED SURGICAL ELECTRIC INSTRUMENT— 510(k) K120040
Substantially EquivalentSterilmed, Inc.
FDA 510(k) clearance K120040 for REPROCESSED SURGICAL ELECTRIC INSTRUMENT, Substantially Equivalent on 2012-10-05. 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
- Maple Grove, 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.