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FDA 510(k)

ULTRALITH ULTRASONIC LITHOTRIPSY SYSTEM

K-Number: K850298 · 1985-03-05

ApplicantCabot Medical Corp.
Decision Date1985-03-05
Product CodeFEO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ULTRALITH ULTRASONIC LITHOTRIPSY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cabot Medical Corp.. It received FDA 510(k) clearance on 1985-03-05 under 510(k) number K850298. 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 ULTRALITH ULTRASONIC LITHOTRIPSY SYSTEM?

ULTRALITH ULTRASONIC LITHOTRIPSY SYSTEM is a medical device that received FDA 510(k) clearance on 1985-03-05. The listed applicant is Cabot Medical Corp.. The 510(k) number is K850298.

When did ULTRALITH ULTRASONIC LITHOTRIPSY SYSTEM receive FDA 510(k) clearance?

ULTRALITH ULTRASONIC LITHOTRIPSY SYSTEM received FDA 510(k) clearance on 1985-03-05, under 510(k) number K850298.

Who is the listed applicant for ULTRALITH ULTRASONIC LITHOTRIPSY SYSTEM?

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

What is the FDA product code for ULTRALITH ULTRASONIC LITHOTRIPSY SYSTEM?

The FDA product code for ULTRALITH ULTRASONIC LITHOTRIPSY SYSTEM is FEO.

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Other records listing Cabot Medical Corp. 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.

K960148CIRCON-SURGITEK CLASSIC DOUBLE PIGTAIL URETERAL STENTK946109CABOT MEDICAL REUSABLE BIPOLAR CUTTING FORCEPSK951972CABOT MEDICAL ULTRA FLOW CYSTOURETHROSCOPE SYSTEM WITH OPERATING & DIAGNOSTIC SHEATHSK951714CABOT MEDICAL-SURGITEK ULTRAGOLD PLUS SIDE-FIRING UROLOGIC LASER FIBERK941743CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMPK9341153000 ELECTRONIC INSUFFLATOR MODIFICATION

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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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