FDA 510(k)

SURGIN GENISIS PHACOEMULSIFIER

K-Number: K954241 · 1995-12-01

ApplicantSurgeon Surgical Instrumentation, Inc.

Decision Date1995-12-01

Product CodeHQC

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

SURGIN GENISIS PHACOEMULSIFIER is the device name listed in this FDA 510(k) record. The listed applicant is Surgeon Surgical Instrumentation, Inc.. It received FDA 510(k) clearance on 1995-12-01 under 510(k) number K954241. 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 SURGIN GENISIS PHACOEMULSIFIER?

SURGIN GENISIS PHACOEMULSIFIER is a medical device that received FDA 510(k) clearance on 1995-12-01. The listed applicant is Surgeon Surgical Instrumentation, Inc.. The 510(k) number is K954241.

When did SURGIN GENISIS PHACOEMULSIFIER receive FDA 510(k) clearance?

SURGIN GENISIS PHACOEMULSIFIER received FDA 510(k) clearance on 1995-12-01, under 510(k) number K954241.

Who is the listed applicant for SURGIN GENISIS PHACOEMULSIFIER?

The FDA 510(k) record lists Surgeon Surgical Instrumentation, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGIN GENISIS PHACOEMULSIFIER?

The FDA product code for SURGIN GENISIS PHACOEMULSIFIER 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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Surgeon Surgical Instrumentation, Inc. as applicant

K932281VERRES NEEDLE K922038CO2 INSUFFLATION TUBING K904010SURGICAL ASPIRATOR KIT K890447HEMORRHAGE OCCLUDOR K880543UNI-PORT K881232SURGIN EYE SHIELD

View all 10 devices →

Related Devices (Code: HQC)

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 Lomb K252052Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)Bausch and Lomb, Incorporated K250501System SophiThis AG K243395MICOR 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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.