Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DUODENOSCOPE, MOLEL TX-6

K-Number: K770754 · 1977-04-28

ApplicantAmerican Cystocope Makers, Inc.
Decision Date1977-04-28
Product CodeFOG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DUODENOSCOPE, MOLEL TX-6 is the device name listed in this FDA 510(k) record. The listed applicant is American Cystocope Makers, Inc.. It received FDA 510(k) clearance on 1977-04-28 under 510(k) number K770754. The device is classified under product code FOG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUODENOSCOPE, MOLEL TX-6?

DUODENOSCOPE, MOLEL TX-6 is a medical device that received FDA 510(k) clearance on 1977-04-28. The listed applicant is American Cystocope Makers, Inc.. The 510(k) number is K770754.

When did DUODENOSCOPE, MOLEL TX-6 receive FDA 510(k) clearance?

DUODENOSCOPE, MOLEL TX-6 received FDA 510(k) clearance on 1977-04-28, under 510(k) number K770754.

Who is the listed applicant for DUODENOSCOPE, MOLEL TX-6?

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

What is the FDA product code for DUODENOSCOPE, MOLEL TX-6?

The FDA product code for DUODENOSCOPE, MOLEL TX-6 is FOG.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing American Cystocope Makers, 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.

K832040STERILE FLUID PRODUCING UNIT #EP550K812637ACMI BIPOLAR HEMOSTATIC SOURCEK811218ACMI ASPIRATOR KIT #8808K803214ACMI BIPOLAR HEMOSTATIC ELECTRODEK791182ACMI RIGI-FLEX NEPHORSCOPEK760822MODEL TX-8 PANENDOSCOPE

View all 9 devices →

Related Devices (Code: FOG)

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.

K973128OLYMPUS NA-10J-1 ASPIRATION NEEDLEOlympus America, Inc.K962182BURLEW INFANT HOODPromedic, Inc.K955482SWIFT INFANT OXYGEN HOOD-REUSABLE (MODIFICATION)Advantage Medical Services, Inc.K830781ENDO-GUARDJayco PharmaceuticalsK792144DISPOSA-HOODUtah Medical Products, Inc.K791861OXYGEN HOODSAnn Arbor Plastics, 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.

↑