Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

KELLY INFLATABLE T DRAIN

K-Number: K823428 · 1983-01-18

Decision Date1983-01-18
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KELLY INFLATABLE T DRAIN is the device name listed in this FDA 510(k) record. The listed applicant is Akron Catheter, Inc.. It received FDA 510(k) clearance on 1983-01-18 under 510(k) number K823428. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KELLY INFLATABLE T DRAIN?

KELLY INFLATABLE T DRAIN is a medical device that received FDA 510(k) clearance on 1983-01-18. The listed applicant is Akron Catheter, Inc.. The 510(k) number is K823428.

When did KELLY INFLATABLE T DRAIN receive FDA 510(k) clearance?

KELLY INFLATABLE T DRAIN received FDA 510(k) clearance on 1983-01-18, under 510(k) number K823428.

Who is the listed applicant for KELLY INFLATABLE T DRAIN?

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

What is the FDA product code for KELLY INFLATABLE T DRAIN?

The FDA product code for KELLY INFLATABLE T DRAIN is FGE.

Related Clinical Trials

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.

Other records listing Akron Catheter, Inc. as applicant

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.

Related Devices (Code: FGE)

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.

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.

↑