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FDA 510(k)

REPROCESSED HARMONIC SCALPELS

K-Number: K050343 · 2005-04-12

ApplicantSterilmed, Inc.
Decision Date2005-04-12
Product CodeNLQ
DecisionSubstantially Equivalent

Device Summary

REPROCESSED HARMONIC SCALPELS is the device name listed in this FDA 510(k) record. The listed applicant is Sterilmed, Inc.. It received FDA 510(k) clearance on 2005-04-12 under 510(k) number K050343. The device is classified under product code NLQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REPROCESSED HARMONIC SCALPELS?

REPROCESSED HARMONIC SCALPELS is a medical device that received FDA 510(k) clearance on 2005-04-12. The listed applicant is Sterilmed, Inc.. The 510(k) number is K050343.

When did REPROCESSED HARMONIC SCALPELS receive FDA 510(k) clearance?

REPROCESSED HARMONIC SCALPELS received FDA 510(k) clearance on 2005-04-12, under 510(k) number K050343.

Who is the listed applicant for REPROCESSED HARMONIC SCALPELS?

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 HARMONIC SCALPELS?

The FDA product code for REPROCESSED HARMONIC SCALPELS is NLQ.

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Other records listing Sterilmed, Inc. as applicant

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Related Devices (Code: NLQ)

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.

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 SolutionsK241606Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length (HAR1136)Stryker Sustainability SolutionsK233471Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136)Stryker Sustainability SolutionsK202554Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced HemostasisStryker Sustainability SolutionsK193563Medline ReNewal Reprocessed Harmonic ACE+7 ShearsSurgical Instrument Service and Savings Inc.(Dba Medline RenK190610Reprocessed 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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