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FDA 510(k)

REPROCESSED HARMONIC SCALPEL

K-Number: K083060 · 2009-01-09

ApplicantSterilmed, Inc.
Decision Date2009-01-09
Product CodeNLQ
DecisionSubstantially Equivalent

Device Summary

REPROCESSED HARMONIC SCALPEL is the device name listed in this FDA 510(k) record. The listed applicant is Sterilmed, Inc.. It received FDA 510(k) clearance on 2009-01-09 under 510(k) number K083060. The device is classified under product code NLQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REPROCESSED HARMONIC SCALPEL?

REPROCESSED HARMONIC SCALPEL is a medical device that received FDA 510(k) clearance on 2009-01-09. The listed applicant is Sterilmed, Inc.. The 510(k) number is K083060.

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

REPROCESSED HARMONIC SCALPEL received FDA 510(k) clearance on 2009-01-09, under 510(k) number K083060.

Who is the listed applicant for REPROCESSED HARMONIC SCALPEL?

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 SCALPEL?

The FDA product code for REPROCESSED HARMONIC SCALPEL 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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