Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis

K-Number: K182272 · 2019-04-15

ApplicantSterilmed, Inc.
Decision Date2019-04-15
Product CodeNLQ
DecisionSubstantially Equivalent

Device Summary

Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis is a medical device manufactured by Sterilmed, Inc.. It received FDA 510(k) clearance on 2019-04-15 under approval number K182272. The device is classified under product code NLQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis?

Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis is a medical device that received FDA 510(k) clearance on 2019-04-15. It is manufactured by Sterilmed, Inc.. The 510(k) number is K182272.

When was Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis approved by the FDA?

Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis received FDA 510(k) clearance on 2019-04-15, under approval number K182272.

What company makes Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis?

Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis is manufactured by Sterilmed, Inc..

What is the FDA product code for Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis?

The FDA product code for Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis is NLQ.

Related Clinical Trials

NCT06608485 A Study of HARMONIC 700 Shears With Advanced Hemostasis in Pediatric and Adult Surgical Procedures RECRUITING NCT07517783 "Comparison of Clip-Based and Clipless Laparoscopic Gallbladder Surgery in Controlling Bleeding" COMPLETED

Other Devices by Sterilmed, Inc.

K161700SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters K161086Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm) K153006Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter K152090Reprocessed Steerable Introducer K152134Reprocessed Vessel Sealer K190478Reprocessed ViewFlex™ Xtra ICE Catheter

View all 9 devices →

Related Devices (Code: NLQ)

K151405Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue TechnologySurgical Instrument Services and Savings(Dba Medline Renewal K170955Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorSurgical Instrument Service and Savings Inc.(Dba Medline Ren K170456Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyStryker Sustainability Solutions K161693Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced HemostasisStryker Sustainability Solutions K173627Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorSurgical Instrument Service and Savings, Inc. K190610Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologySterilmed, Inc.

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.

↑