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FDA 510(k)

ENTEROTUBE II

K-Number: K781236 · 1978-08-31

ApplicantHoffmann-La Roche, Inc.
Decision Date1978-08-31
Product CodeJSS
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ENTEROTUBE II is the device name listed in this FDA 510(k) record. The listed applicant is Hoffmann-La Roche, Inc.. It received FDA 510(k) clearance on 1978-08-31 under 510(k) number K781236. The device is classified under product code JSS. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENTEROTUBE II?

ENTEROTUBE II is a medical device that received FDA 510(k) clearance on 1978-08-31. The listed applicant is Hoffmann-La Roche, Inc.. The 510(k) number is K781236.

When did ENTEROTUBE II receive FDA 510(k) clearance?

ENTEROTUBE II received FDA 510(k) clearance on 1978-08-31, under 510(k) number K781236.

Who is the listed applicant for ENTEROTUBE II?

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

What is the FDA product code for ENTEROTUBE II?

The FDA product code for ENTEROTUBE II is JSS.

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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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