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FDA 510(k)

Graft Delivery, DePuy Synthes

K-Number: K173385 · 2017-11-30

Decision Date2017-11-30
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Graft Delivery, DePuy Synthes is the device name listed in this FDA 510(k) record. The listed applicant is Micromedics, Inc. (D/B/A Nordson Medical). It received FDA 510(k) clearance on 2017-11-30 under 510(k) number K173385. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Graft Delivery, DePuy Synthes?

Graft Delivery, DePuy Synthes is a medical device that received FDA 510(k) clearance on 2017-11-30. The listed applicant is Micromedics, Inc. (D/B/A Nordson Medical). The 510(k) number is K173385.

When did Graft Delivery, DePuy Synthes receive FDA 510(k) clearance?

Graft Delivery, DePuy Synthes received FDA 510(k) clearance on 2017-11-30, under 510(k) number K173385.

Who is the listed applicant for Graft Delivery, DePuy Synthes?

The FDA 510(k) record lists Micromedics, Inc. (D/B/A Nordson Medical) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Graft Delivery, DePuy Synthes?

The FDA product code for Graft Delivery, DePuy Synthes is FMF.

Other records listing Micromedics, Inc. (D/B/A Nordson Medical) 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: FMF)

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