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FDA 510(k)

EXONIX

K-Number: K984199 · 1999-02-17

ApplicantFibra Sonics, Inc.
Decision Date1999-02-17
Product CodeIMI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

EXONIX is the device name listed in this FDA 510(k) record. The listed applicant is Fibra Sonics, Inc.. It received FDA 510(k) clearance on 1999-02-17 under 510(k) number K984199. The device is classified under product code IMI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXONIX?

EXONIX is a medical device that received FDA 510(k) clearance on 1999-02-17. The listed applicant is Fibra Sonics, Inc.. The 510(k) number is K984199.

When did EXONIX receive FDA 510(k) clearance?

EXONIX received FDA 510(k) clearance on 1999-02-17, under 510(k) number K984199.

Who is the listed applicant for EXONIX?

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

What is the FDA product code for EXONIX?

The FDA product code for EXONIX is IMI.

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Other records listing Fibra Sonics, 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.

K993046FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000K984143FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEMK983199FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 1000 CONSOLE MODELK980930FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 2100 USSTAK842024ULTRASONIC LITHOTRIPTOR 300AK834453PHACO FRAGMENTOR GT-1

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Related Devices (Code: IMI)

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.

K240788Ultrasound StimulatorJkh Health Co., Ltd.K230472Sonopuls 190Enraf-Nonius, B.V.K222098ManaSport+Manamed, Inc.K210284ManaSportManamed, Inc.K202788Sonomed IV, Sonomed VCarci Industria E Comercio DE Aparelhos Cirurgicos E OrtoK160378BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)Brh Medical , Ltd.

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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