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FDA 510(k)

CANDELA DIRECTABLE BILIARY CATHETER SYSTEM

K-Number: K900904 · 1990-05-11

Decision Date1990-05-11
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CANDELA DIRECTABLE BILIARY CATHETER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Candela Laser Corp.. It received FDA 510(k) clearance on 1990-05-11 under 510(k) number K900904. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CANDELA DIRECTABLE BILIARY CATHETER SYSTEM?

CANDELA DIRECTABLE BILIARY CATHETER SYSTEM is a medical device that received FDA 510(k) clearance on 1990-05-11. The listed applicant is Candela Laser Corp.. The 510(k) number is K900904.

When did CANDELA DIRECTABLE BILIARY CATHETER SYSTEM receive FDA 510(k) clearance?

CANDELA DIRECTABLE BILIARY CATHETER SYSTEM received FDA 510(k) clearance on 1990-05-11, under 510(k) number K900904.

Who is the listed applicant for CANDELA DIRECTABLE BILIARY CATHETER SYSTEM?

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

What is the FDA product code for CANDELA DIRECTABLE BILIARY CATHETER SYSTEM?

The FDA product code for CANDELA DIRECTABLE BILIARY CATHETER SYSTEM is FGE.

Related Clinical Trials

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.

Other records listing Candela Laser 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.

View all 43 devices →

Related Devices (Code: FGE)

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.

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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