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FDA 510(k)

ENTEROSCOPE

K-Number: K840722 · 1984-06-07

ApplicantTrimedyne, Inc.
Decision Date1984-06-07
Product CodeFDA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENTEROSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Trimedyne, Inc.. It received FDA 510(k) clearance on 1984-06-07 under 510(k) number K840722. The device is classified under product code FDA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENTEROSCOPE?

ENTEROSCOPE is a medical device that received FDA 510(k) clearance on 1984-06-07. The listed applicant is Trimedyne, Inc.. The 510(k) number is K840722.

When did ENTEROSCOPE receive FDA 510(k) clearance?

ENTEROSCOPE received FDA 510(k) clearance on 1984-06-07, under 510(k) number K840722.

Who is the listed applicant for ENTEROSCOPE?

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

What is the FDA product code for ENTEROSCOPE?

The FDA product code for ENTEROSCOPE is FDA.

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Other records listing Trimedyne, Inc. as applicant

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K053457VAPORMAX IIK050412VAPORMAXK043012OMNIPULSE MINI, MODEL 2120K041660TRIMEDYNE HOLMIUM LASER SYSTEMSK022655TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATHK013974RMNIPULSE HOLMIUM LASER SYSTEM/1210; MAX/1210-VHP; JR. 1230-30; N/A 1500-A

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Related Devices (Code: FDA)

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.

K260314Ancora-SBAspero Medical, Inc.K251204FUJIFILM Stiffening Wire Device (SW-2000)FUJIFILM Healthcare Americas CorporationK233321Double Balloon Endoscope EN-840T, Over-tube TS-1214CFUJIFILM Healthcare Americas CorporationK231323Ancora-SBAspero Medical, Inc.K223295Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500DFujifilm CorporatonK213195Balloon BS-3Fujifilm Corporation

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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