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FDA 510(k)

TRANSENDOSCOPIC INJECTION CATHETER TEI

K-Number: K821336 · 1982-05-21

ApplicantSounson Research Co., Inc.
Decision Date1982-05-21
Product CodeKNY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TRANSENDOSCOPIC INJECTION CATHETER TEI is the device name listed in this FDA 510(k) record. The listed applicant is Sounson Research Co., Inc.. It received FDA 510(k) clearance on 1982-05-21 under 510(k) number K821336. The device is classified under product code KNY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRANSENDOSCOPIC INJECTION CATHETER TEI?

TRANSENDOSCOPIC INJECTION CATHETER TEI is a medical device that received FDA 510(k) clearance on 1982-05-21. The listed applicant is Sounson Research Co., Inc.. The 510(k) number is K821336.

When did TRANSENDOSCOPIC INJECTION CATHETER TEI receive FDA 510(k) clearance?

TRANSENDOSCOPIC INJECTION CATHETER TEI received FDA 510(k) clearance on 1982-05-21, under 510(k) number K821336.

Who is the listed applicant for TRANSENDOSCOPIC INJECTION CATHETER TEI?

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

What is the FDA product code for TRANSENDOSCOPIC INJECTION CATHETER TEI?

The FDA product code for TRANSENDOSCOPIC INJECTION CATHETER TEI is KNY.

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Related Devices (Code: KNY)

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.

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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.

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