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FDA 510(k)

SALUTE, MODEL 3022

K-Number: K014286 · 2002-03-08

ApplicantOnux Medical, Inc.
Decision Date2002-03-08
Product CodeGDW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SALUTE, MODEL 3022 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 2002-03-08 under 510(k) number K014286. 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, MODEL 3022?

SALUTE, MODEL 3022 is a medical device that received FDA 510(k) clearance on 2002-03-08. The listed applicant is Onux Medical, Inc.. The 510(k) number is K014286.

When did SALUTE, MODEL 3022 receive FDA 510(k) clearance?

SALUTE, MODEL 3022 received FDA 510(k) clearance on 2002-03-08, under 510(k) number K014286.

Who is the listed applicant for SALUTE, MODEL 3022?

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, MODEL 3022?

The FDA product code for SALUTE, MODEL 3022 is GDW.

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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 SYSTEMK010620ENDOSCOPIC STAPLE REMOVAL INSTRUMENTK003522SALUTE

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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