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FDA 510(k)

SALUTE

K-Number: K003522 · 2001-02-13

ApplicantOnux Medical, Inc.
Decision Date2001-02-13
Product CodeGDW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SALUTE is the device name listed in this FDA 510(k) record. The listed applicant is Onux Medical, Inc.. It received FDA 510(k) clearance on 2001-02-13 under 510(k) number K003522. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SALUTE?

SALUTE is a medical device that received FDA 510(k) clearance on 2001-02-13. The listed applicant is Onux Medical, Inc.. The 510(k) number is K003522.

When did SALUTE receive FDA 510(k) clearance?

SALUTE received FDA 510(k) clearance on 2001-02-13, under 510(k) number K003522.

Who is the listed applicant for SALUTE?

The FDA 510(k) record lists Onux Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SALUTE?

The FDA product code for SALUTE is GDW.

Related Clinical Trials

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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Other records listing Onux Medical, Inc. 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.

K023372NON-BIOABSORBABLE STAPLEK022777MANUAL TOUCHE SYSTEMK014286SALUTE, MODEL 3022K010620ENDOSCOPIC STAPLE REMOVAL INSTRUMENT

Related Devices (Code: GDW)

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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