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FDA 510(k)

OCUSYSTEM ART ADVANTAGE

K-Number: K961243 · 1996-07-10

ApplicantSurgical Design Corp.
Decision Date1996-07-10
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OCUSYSTEM ART ADVANTAGE is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Design Corp.. It received FDA 510(k) clearance on 1996-07-10 under 510(k) number K961243. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OCUSYSTEM ART ADVANTAGE?

OCUSYSTEM ART ADVANTAGE is a medical device that received FDA 510(k) clearance on 1996-07-10. The listed applicant is Surgical Design Corp.. The 510(k) number is K961243.

When did OCUSYSTEM ART ADVANTAGE receive FDA 510(k) clearance?

OCUSYSTEM ART ADVANTAGE received FDA 510(k) clearance on 1996-07-10, under 510(k) number K961243.

Who is the listed applicant for OCUSYSTEM ART ADVANTAGE?

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

What is the FDA product code for OCUSYSTEM ART ADVANTAGE?

The FDA product code for OCUSYSTEM ART ADVANTAGE is HQC.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Surgical Design Corp. 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.

K991852OCUSYSTEM ART ADVANTAGE, MODEL 995K934817SURGICAL DESIGN CORPORATION MODEL 700 LOW PRESSURE MATTRESS

Related Devices (Code: HQC)

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.

K261264Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite™ Pack (SE5423); 23 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423B); 25 ga. Posterior Elite™ Pack (SE5425); 25 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5425B); 27 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5427B); 23 ga. Bi-Blade™+ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423BB+); 25 ga. Bi-Blade™+Bausch and LombK252052Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)Bausch and Lomb, IncorporatedK250501System SophiThis AGK243395MICOR 700 with Auto I/ACarl Zeiss Meditec Cataract Technology, Inc.K242801MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)Carl Zeiss Meditec Cataract Technology, Inc.K240169Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)Bausch and Lomb, Incorporated

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.

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