FDA 510(k)

REPROCESSED SURGICAL ELECTRIC INSTRUMENT

K-Number: K120040 · 2012-10-05

Decision Date2012-10-05

Product CodeNUJ

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

REPROCESSED SURGICAL ELECTRIC INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Sterilmed, Inc.. It received FDA 510(k) clearance on 2012-10-05 under 510(k) number K120040. The device is classified under product code NUJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REPROCESSED SURGICAL ELECTRIC INSTRUMENT?

REPROCESSED SURGICAL ELECTRIC INSTRUMENT is a medical device that received FDA 510(k) clearance on 2012-10-05. The listed applicant is Sterilmed, Inc.. The 510(k) number is K120040.

When did REPROCESSED SURGICAL ELECTRIC INSTRUMENT receive FDA 510(k) clearance?

REPROCESSED SURGICAL ELECTRIC INSTRUMENT received FDA 510(k) clearance on 2012-10-05, under 510(k) number K120040.

Who is the listed applicant for REPROCESSED SURGICAL ELECTRIC INSTRUMENT?

The FDA 510(k) record lists Sterilmed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REPROCESSED SURGICAL ELECTRIC INSTRUMENT?

The FDA product code for REPROCESSED SURGICAL ELECTRIC INSTRUMENT is NUJ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Sterilmed, Inc. as applicant

K254149Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825); Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657484); Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510826); Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657485)K240826Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter K190478Reprocessed ViewFlex™ Xtra ICE Catheter K190610Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology K182272Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis K161700SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters

View all 60 devices →

Related Devices (Code: NUJ)

K232511Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)Surgical Instrument Service and Savings, Inc.K230251Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)Stryker Sustainability Solutions K220411Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)Stryker Sustainability Solutions K211203Green OR Reprocessed Aquamantys Bipolar SealerGreen Or, LLC K191073Vein360 Endovenous Radiofrequency Ablation (RFA) CatheterVein 360, LLC K182588Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/DividerSurgical Instrument Service and Savings Inc.(Dba Medline Ren

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.