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FDA 510(k)

Fehling-Punches

K-Number: K153243 · 2016-08-04

Decision Date2016-08-04
Product CodeHAE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Fehling-Punches is the device name listed in this FDA 510(k) record. The listed applicant is Fehling Instruments GmbH & Co. KG. It received FDA 510(k) clearance on 2016-08-04 under 510(k) number K153243. The device is classified under product code HAE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fehling-Punches?

Fehling-Punches is a medical device that received FDA 510(k) clearance on 2016-08-04. The listed applicant is Fehling Instruments GmbH & Co. KG. The 510(k) number is K153243.

When did Fehling-Punches receive FDA 510(k) clearance?

Fehling-Punches received FDA 510(k) clearance on 2016-08-04, under 510(k) number K153243.

Who is the listed applicant for Fehling-Punches?

The FDA 510(k) record lists Fehling Instruments GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fehling-Punches?

The FDA product code for Fehling-Punches is HAE.

Other records listing Fehling Instruments GmbH & Co. KG 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: HAE)

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

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