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FDA 510(k)

ROCCIA® MultiLIF

K-Number: K171434 · 2017-12-21

Decision Date2017-12-21
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ROCCIA® MultiLIF is the device name listed in this FDA 510(k) record. The listed applicant is Silony Medical GmbH. It received FDA 510(k) clearance on 2017-12-21 under 510(k) number K171434. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROCCIA® MultiLIF?

ROCCIA® MultiLIF is a medical device that received FDA 510(k) clearance on 2017-12-21. The listed applicant is Silony Medical GmbH. The 510(k) number is K171434.

When did ROCCIA® MultiLIF receive FDA 510(k) clearance?

ROCCIA® MultiLIF received FDA 510(k) clearance on 2017-12-21, under 510(k) number K171434.

Who is the listed applicant for ROCCIA® MultiLIF?

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

What is the FDA product code for ROCCIA® MultiLIF?

The FDA product code for ROCCIA® MultiLIF is MAX.

Other records listing Silony Medical GmbH 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.

View all 13 devices →

Related Devices (Code: MAX)

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.