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FDA 510(k)

D-Clip; D-Clip Applier

K-Number: K180757 · 2019-04-12

ApplicantPeter Lazic GmbH
Decision Date2019-04-12
Product CodeHCH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

D-Clip; D-Clip Applier is the device name listed in this FDA 510(k) record. The listed applicant is Peter Lazic GmbH. It received FDA 510(k) clearance on 2019-04-12 under 510(k) number K180757. The device is classified under product code HCH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the D-Clip; D-Clip Applier?

D-Clip; D-Clip Applier is a medical device that received FDA 510(k) clearance on 2019-04-12. The listed applicant is Peter Lazic GmbH. The 510(k) number is K180757.

When did D-Clip; D-Clip Applier receive FDA 510(k) clearance?

D-Clip; D-Clip Applier received FDA 510(k) clearance on 2019-04-12, under 510(k) number K180757.

Who is the listed applicant for D-Clip; D-Clip Applier?

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

What is the FDA product code for D-Clip; D-Clip Applier?

The FDA product code for D-Clip; D-Clip Applier is HCH.

Related Devices (Code: HCH)

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.

K211183Sugita AVM MicroclipsMizuho America, Inc.

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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