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FDA 510(k)

ULTRASONIC LITHOTRIPTOR 300A

K-Number: K842024 · 1984-12-11

ApplicantFibra Sonics, Inc.
Decision Date1984-12-11
Product CodeFEO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ULTRASONIC LITHOTRIPTOR 300A 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 1984-12-11 under 510(k) number K842024. The device is classified under product code FEO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRASONIC LITHOTRIPTOR 300A?

ULTRASONIC LITHOTRIPTOR 300A is a medical device that received FDA 510(k) clearance on 1984-12-11. The listed applicant is Fibra Sonics, Inc.. The 510(k) number is K842024.

When did ULTRASONIC LITHOTRIPTOR 300A receive FDA 510(k) clearance?

ULTRASONIC LITHOTRIPTOR 300A received FDA 510(k) clearance on 1984-12-11, under 510(k) number K842024.

Who is the listed applicant for ULTRASONIC LITHOTRIPTOR 300A?

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 ULTRASONIC LITHOTRIPTOR 300A?

The FDA product code for ULTRASONIC LITHOTRIPTOR 300A is FEO.

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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-2000K984199EXONIXK984143FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEMK983199FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 1000 CONSOLE MODELK980930FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 2100 USSTAK834453PHACO FRAGMENTOR GT-1

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Related Devices (Code: FEO)

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.

K230893Swiss LthoClast TrilogyE.M.S Electro Medical Systems S.AK182490Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.AK181997Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.AK181364Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.AK173234Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.AK171024ShockPulse-SE Lithotripsy SystemCybersonics, 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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