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FDA 510(k)

TUTA HEALTHCARE ARTHROSCOPY FLUSHING SET, MODEL 80.601

K-Number: K020083 · 2002-02-12

ApplicantTuta Healthcare Pty Limited
Decision Date2002-02-12
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TUTA HEALTHCARE ARTHROSCOPY FLUSHING SET, MODEL 80.601 is the device name listed in this FDA 510(k) record. The listed applicant is Tuta Healthcare Pty Limited. It received FDA 510(k) clearance on 2002-02-12 under 510(k) number K020083. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TUTA HEALTHCARE ARTHROSCOPY FLUSHING SET, MODEL 80.601?

TUTA HEALTHCARE ARTHROSCOPY FLUSHING SET, MODEL 80.601 is a medical device that received FDA 510(k) clearance on 2002-02-12. The listed applicant is Tuta Healthcare Pty Limited. The 510(k) number is K020083.

When did TUTA HEALTHCARE ARTHROSCOPY FLUSHING SET, MODEL 80.601 receive FDA 510(k) clearance?

TUTA HEALTHCARE ARTHROSCOPY FLUSHING SET, MODEL 80.601 received FDA 510(k) clearance on 2002-02-12, under 510(k) number K020083.

Who is the listed applicant for TUTA HEALTHCARE ARTHROSCOPY FLUSHING SET, MODEL 80.601?

The FDA 510(k) record lists Tuta Healthcare Pty Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TUTA HEALTHCARE ARTHROSCOPY FLUSHING SET, MODEL 80.601?

The FDA product code for TUTA HEALTHCARE ARTHROSCOPY FLUSHING SET, MODEL 80.601 is HRX.

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Other records listing Tuta Healthcare Pty Limited as applicant

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.

K023595BURETTE-IN LINE (150 ML)K023039BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015

Related Devices (Code: HRX)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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