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FDA 510(k)

BLACKSTAR(TM) STAR SYSTEM

K-Number: K945659 · 1995-01-09

ApplicantXomed-Treace, Inc.
Decision Date1995-01-09
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BLACKSTAR(TM) STAR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Xomed-Treace, Inc.. It received FDA 510(k) clearance on 1995-01-09 under 510(k) number K945659. The device is classified under product code ERL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLACKSTAR(TM) STAR SYSTEM?

BLACKSTAR(TM) STAR SYSTEM is a medical device that received FDA 510(k) clearance on 1995-01-09. The listed applicant is Xomed-Treace, Inc.. The 510(k) number is K945659.

When did BLACKSTAR(TM) STAR SYSTEM receive FDA 510(k) clearance?

BLACKSTAR(TM) STAR SYSTEM received FDA 510(k) clearance on 1995-01-09, under 510(k) number K945659.

Who is the listed applicant for BLACKSTAR(TM) STAR SYSTEM?

The FDA 510(k) record lists Xomed-Treace, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BLACKSTAR(TM) STAR SYSTEM?

The FDA product code for BLACKSTAR(TM) STAR SYSTEM is ERL.

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Other records listing Xomed-Treace, Inc. 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.

K940028ENDOSCOPE SHEATHK941407TYMPANOSTOMY (VENTILATION) TUBEK932771BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCEK933672XOMED-TREACE SCOPESHEATHK934426NERVE INTEGRITY MONITOR-2 (NIM-2 XL)K933105XOMED-TREACE RIGID ROD LENS ENDOSCOPE

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Related Devices (Code: ERL)

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.

K243280Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)W&H Dentalwerk Buermoos GmbHK233958hekaDrillZethon, Ltd.K221184ORiGO SystemBien-Air Surgery SAK213221AMADEO, M-UK1015 (incl. attachments and accessories)W&H Dentalwerk Buermoss GmbHK212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.K211490Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000Stryker Corporation

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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