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FDA 510(k)

Star Tissue Marker

K-Number: K170905 · 2017-04-27

ApplicantScion Medical Technologies, LLC
Decision Date2017-04-27
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Star Tissue Marker is the device name listed in this FDA 510(k) record. The listed applicant is Scion Medical Technologies, LLC. It received FDA 510(k) clearance on 2017-04-27 under 510(k) number K170905. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Star Tissue Marker?

Star Tissue Marker is a medical device that received FDA 510(k) clearance on 2017-04-27. The listed applicant is Scion Medical Technologies, LLC. The 510(k) number is K170905.

When did Star Tissue Marker receive FDA 510(k) clearance?

Star Tissue Marker received FDA 510(k) clearance on 2017-04-27, under 510(k) number K170905.

Who is the listed applicant for Star Tissue Marker?

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

What is the FDA product code for Star Tissue Marker?

The FDA product code for Star Tissue Marker is NEU.

Other records listing Scion Medical Technologies, LLC 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.

K161234CASSI II Rotational Core Biopsy System

Related Devices (Code: NEU)

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.

K253761HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape)Devicor Medical Products, Inc.K253888MOLLI 2 SystemStryker EndoscopyK252892SCOUT MD Surgical Guidance SystemMerit Medical Systems, Inc.K251989VizMark Preloaded Tissue Marker Device (VM-0001)Breast-Med, Inc.K251748MammoSTAR Biopsy Site IdentifierCarbon Medical Technologies, Inc.K243642UltraCor™ Twirl™ Breast Tissue MarkerBard Peripheral Vascular, 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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