FDA 510(k)

GASTRO ENTEROLOGICAL BIOPTOME

K-Number: K894419 · 1989-09-08

Decision Date1989-09-08

Product CodeKNW

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

GASTRO ENTEROLOGICAL BIOPTOME is the device name listed in this FDA 510(k) record. The listed applicant is Symbiosis Corp.. It received FDA 510(k) clearance on 1989-09-08 under 510(k) number K894419. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GASTRO ENTEROLOGICAL BIOPTOME?

GASTRO ENTEROLOGICAL BIOPTOME is a medical device that received FDA 510(k) clearance on 1989-09-08. The listed applicant is Symbiosis Corp.. The 510(k) number is K894419.

When did GASTRO ENTEROLOGICAL BIOPTOME receive FDA 510(k) clearance?

GASTRO ENTEROLOGICAL BIOPTOME received FDA 510(k) clearance on 1989-09-08, under 510(k) number K894419.

Who is the listed applicant for GASTRO ENTEROLOGICAL BIOPTOME?

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

What is the FDA product code for GASTRO ENTEROLOGICAL BIOPTOME?

The FDA product code for GASTRO ENTEROLOGICAL BIOPTOME is KNW.

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Other records listing Symbiosis Corp. as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.