FDA 510(k)

Ace Medical Surgical Instruments

K-Number: K200387 · 2020-07-21

Decision Date2020-07-21

Product CodeHAE

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Ace Medical Surgical Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Ace Medical. It received FDA 510(k) clearance on 2020-07-21 under 510(k) number K200387. 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 Ace Medical Surgical Instruments?

Ace Medical Surgical Instruments is a medical device that received FDA 510(k) clearance on 2020-07-21. The listed applicant is Ace Medical. The 510(k) number is K200387.

When did Ace Medical Surgical Instruments receive FDA 510(k) clearance?

Ace Medical Surgical Instruments received FDA 510(k) clearance on 2020-07-21, under 510(k) number K200387.

Who is the listed applicant for Ace Medical Surgical Instruments?

The FDA 510(k) record lists Ace Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ace Medical Surgical Instruments?

The FDA product code for Ace Medical Surgical Instruments is HAE.

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.

K242759Geister K-Rex rongeursGeister Medizin Technik GmbH K223596SQ.line KERRISONAesculap, Inc.K230256Rebellion, Phantom Multi-Bite Kerrison RongeurMorpheus AG K221818Rebellion; Phantom Multi-Bite Kerrison RongeurMorpheus AG K210741KLS Martin Neuro RongeursKLS-Martin L.P.K200768Rebellion, Phantom Multi-Bite Kerrison RongeurMorpheus AG

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.