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FDA 510(k)

ULTRA-CBX

K-Number: K991486 · 1999-11-05

ApplicantMedcanica, Inc.
Decision Date1999-11-05
Product CodeDWZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ULTRA-CBX is the device name listed in this FDA 510(k) record. The listed applicant is Medcanica, Inc.. It received FDA 510(k) clearance on 1999-11-05 under 510(k) number K991486. The device is classified under product code DWZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRA-CBX?

ULTRA-CBX is a medical device that received FDA 510(k) clearance on 1999-11-05. The listed applicant is Medcanica, Inc.. The 510(k) number is K991486.

When did ULTRA-CBX receive FDA 510(k) clearance?

ULTRA-CBX received FDA 510(k) clearance on 1999-11-05, under 510(k) number K991486.

Who is the listed applicant for ULTRA-CBX?

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

What is the FDA product code for ULTRA-CBX?

The FDA product code for ULTRA-CBX is DWZ.

Related Clinical Trials

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Other records listing Medcanica, 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.

K011373INSTRUMENT DAMPING PORTK011349INTERCOSTAL LOCKABLE-DIRECTABLE PORTK994232PHALANGEAL FIXATION SYSTEMK991064METACARPAL FIXATION SYSTEM

Related Devices (Code: DWZ)

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.

K252722Biopsy ForcepsFehling Instruments GmbHK170726Biopsy ForcepsFehling Instruments GmbH & Co. KGK072051NOVATOME, MODEL: SU101-50Scholten Surgical Instruments, Inc.K010473SPARROWHAWK DISPOSABLEAtc Technologies, Inc.K000409MODIFICATION TO T-REX BIOPSY FORCEPSBoston Scientific CorpK974175HEARTPORT ENDOAORTIC CLAMP CATHETERHeartport, 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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