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FDA 510(k)

NEEDLE CATHETER JEJUNOSTOMY KIT

K-Number: K822565 · 1982-09-28

ApplicantBio-Research Associates, Inc.
Decision Date1982-09-28
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NEEDLE CATHETER JEJUNOSTOMY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Research Associates, Inc.. It received FDA 510(k) clearance on 1982-09-28 under 510(k) number K822565. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEEDLE CATHETER JEJUNOSTOMY KIT?

NEEDLE CATHETER JEJUNOSTOMY KIT is a medical device that received FDA 510(k) clearance on 1982-09-28. The listed applicant is Bio-Research Associates, Inc.. The 510(k) number is K822565.

When did NEEDLE CATHETER JEJUNOSTOMY KIT receive FDA 510(k) clearance?

NEEDLE CATHETER JEJUNOSTOMY KIT received FDA 510(k) clearance on 1982-09-28, under 510(k) number K822565.

Who is the listed applicant for NEEDLE CATHETER JEJUNOSTOMY KIT?

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

What is the FDA product code for NEEDLE CATHETER JEJUNOSTOMY KIT?

The FDA product code for NEEDLE CATHETER JEJUNOSTOMY KIT is KNT.

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Other records listing Bio-Research Associates, Inc. as applicant

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Related Devices (Code: KNT)

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

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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