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FDA 510(k)

Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis

K-Number: K202554 · 2021-03-16

ApplicantStryker Sustainability Solutions
Decision Date2021-03-16
Product CodeNLQ
DecisionSubstantially Equivalent

Device Summary

Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis is a medical device manufactured by Stryker Sustainability Solutions. It received FDA 510(k) clearance on 2021-03-16 under approval number K202554. The device is classified under product code NLQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis?

Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis is a medical device that received FDA 510(k) clearance on 2021-03-16. It is manufactured by Stryker Sustainability Solutions. The 510(k) number is K202554.

When was Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis approved by the FDA?

Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis received FDA 510(k) clearance on 2021-03-16, under approval number K202554.

What company makes Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis?

Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis is manufactured by Stryker Sustainability Solutions.

What is the FDA product code for Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis?

The FDA product code for Reprocessed HARMONIC ACE+ 7, 5 mm Diameter 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

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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.

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