FDA 510(k)

SITE ULTRASONIC I/A PHACO NEEDLE

K-Number: K882103 · 1988-07-01

ApplicantSite Microsurgical Systems, Inc.

Decision Date1988-07-01

Product CodeHQC

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

SITE ULTRASONIC I/A PHACO NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Site Microsurgical Systems, Inc.. It received FDA 510(k) clearance on 1988-07-01 under 510(k) number K882103. 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 SITE ULTRASONIC I/A PHACO NEEDLE?

SITE ULTRASONIC I/A PHACO NEEDLE is a medical device that received FDA 510(k) clearance on 1988-07-01. The listed applicant is Site Microsurgical Systems, Inc.. The 510(k) number is K882103.

When did SITE ULTRASONIC I/A PHACO NEEDLE receive FDA 510(k) clearance?

SITE ULTRASONIC I/A PHACO NEEDLE received FDA 510(k) clearance on 1988-07-01, under 510(k) number K882103.

Who is the listed applicant for SITE ULTRASONIC I/A PHACO NEEDLE?

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

What is the FDA product code for SITE ULTRASONIC I/A PHACO NEEDLE?

The FDA product code for SITE ULTRASONIC I/A PHACO NEEDLE 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 Site Microsurgical Systems, Inc. as applicant

K925828MODIFIED SITE TXR SYSTEMS K925921MODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTE K931866SITE'S CD II PHACOEMULSIFICATION HANDPIECE K921135IOLAB POWER I.V. POLE K920582180 TIP, 1/A HANDPIECE .3MM END OPENING FOR OPHT.K912902PHACOEMULSIFICATION SYSTEM FOR OPHTHALMIC USE

View all 30 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.