FDA 510(k)

PHACO EMULSIFICATION,IRRIGATION/ASPIRATION TUBE

K-Number: K915118 · 1991-12-27

Decision Date1991-12-27

Product CodeHQC

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

PHACO EMULSIFICATION,IRRIGATION/ASPIRATION TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Ipax, Inc.. It received FDA 510(k) clearance on 1991-12-27 under 510(k) number K915118. 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 PHACO EMULSIFICATION,IRRIGATION/ASPIRATION TUBE?

PHACO EMULSIFICATION,IRRIGATION/ASPIRATION TUBE is a medical device that received FDA 510(k) clearance on 1991-12-27. The listed applicant is Ipax, Inc.. The 510(k) number is K915118.

When did PHACO EMULSIFICATION,IRRIGATION/ASPIRATION TUBE receive FDA 510(k) clearance?

PHACO EMULSIFICATION,IRRIGATION/ASPIRATION TUBE received FDA 510(k) clearance on 1991-12-27, under 510(k) number K915118.

Who is the listed applicant for PHACO EMULSIFICATION,IRRIGATION/ASPIRATION TUBE?

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

What is the FDA product code for PHACO EMULSIFICATION,IRRIGATION/ASPIRATION TUBE?

The FDA product code for PHACO EMULSIFICATION,IRRIGATION/ASPIRATION TUBE 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 Ipax, Inc. as applicant

K200893ProntoPump Sterile Tube Set K971242BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28)K971245BLINK EXTERNAL EYELID WEIGHT K915158SUREBREATH DOME, E-Z BREATHER K914172KPE 230 AM K914221KPE 220 TS, NONSTERILE

View all 18 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.