FDA 510(k)

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

Numéro K : K202554 · 2021-03-16

DemandeurStryker Sustainability Solutions

Date de décision2021-03-16

Code produitNLQ

DécisionSubstantially Equivalent

Résumé du dispositif

Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Sustainability Solutions. It received FDA 510(k) clearance on 2021-03-16 under 510(k) number K202554. The device is classified under product code NLQ. FDA Decision: Substantially Equivalent.

Questions fréquentes

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. The listed applicant is Stryker Sustainability Solutions. The 510(k) number is K202554.

When did Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis receive FDA 510(k) clearance?

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

Who is the listed applicant for Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis?

The FDA 510(k) record lists Stryker Sustainability Solutions as the applicant. This does not by itself establish the device manufacturer.

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.

Essais cliniques associés

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Dispositifs connexes (Code : NLQ)

K250898Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 23cm); Reprocessed HARMONIC 700 Shears (HAR736/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 36cm); Reprocessed HARMONIC 700 Shears (HAR745/Reprocessed HARMONIC 700, 5mm Diameter SHears with Advanced Hemostasis x 45cm)Stryker Sustainability Solutions K241606Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length (HAR1136)Stryker Sustainability Solutions K233471Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136)Stryker Sustainability Solutions K193563Medline ReNewal Reprocessed Harmonic ACE+7 ShearsSurgical Instrument Service and Savings Inc.(Dba Medline Ren K190610Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologySterilmed, Inc.K182272Reprocessed HARMONIC ACE+ 7 Shears with Advanced HemostasisSterilmed, Inc.

Source officielle

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