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FDA 510(k)

CATHETER, CHOLANGIOGRAM, OPERATIVE

K-Number: K772288 · 1978-01-30

ApplicantGesco Intl., Inc.
Decision Date1978-01-30
Product CodeGBZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CATHETER, CHOLANGIOGRAM, OPERATIVE is the device name listed in this FDA 510(k) record. The listed applicant is Gesco Intl., Inc.. It received FDA 510(k) clearance on 1978-01-30 under 510(k) number K772288. The device is classified under product code GBZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CATHETER, CHOLANGIOGRAM, OPERATIVE?

CATHETER, CHOLANGIOGRAM, OPERATIVE is a medical device that received FDA 510(k) clearance on 1978-01-30. The listed applicant is Gesco Intl., Inc.. The 510(k) number is K772288.

When did CATHETER, CHOLANGIOGRAM, OPERATIVE receive FDA 510(k) clearance?

CATHETER, CHOLANGIOGRAM, OPERATIVE received FDA 510(k) clearance on 1978-01-30, under 510(k) number K772288.

Who is the listed applicant for CATHETER, CHOLANGIOGRAM, OPERATIVE?

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

What is the FDA product code for CATHETER, CHOLANGIOGRAM, OPERATIVE?

The FDA product code for CATHETER, CHOLANGIOGRAM, OPERATIVE is GBZ.

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Other records listing Gesco Intl., 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.

K954422PER-Q-CATH MID-LINEK940870UMBILI-CATHK940953UMBILI-CATH-SK940952UMBILI-CATH-S-DLK941672URI-CATH CATHETERK941232THORA-CATH

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Related Devices (Code: GBZ)

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.

K973621PRE-VIEW CHOLANGIOGRAPHY CLAMPNashville Surgical InstrumentsK944790FLEXIBLE LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERApplied Medical ResourcesK942450ENDOPATHEthicon Endo-Surgery, Inc.K932228MICROVASIVE INSURG CHLOANGIOGRAPHIC CATHETERBoston Scientific CorpK926217TERUMO ANGIOGRAPHIC CATHETER FOR LAPOROSCOPIC USETerumo Medical Corp.K926143ANGIOLAPCATH CHOLANGIOGRAPHY KITBd Becton Dickinson Vacutainer Systems Preanalytic

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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