Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PHAKOSYSTEMS MODEL 1000/OMNI PACKS IRRIGATION/ASPIRATION

K-Number: K830871 · 1983-06-02

ApplicantPhakosystems, Inc.
Decision Date1983-06-02
Product CodeHOC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PHAKOSYSTEMS MODEL 1000/OMNI PACKS IRRIGATION/ASPIRATION is the device name listed in this FDA 510(k) record. The listed applicant is Phakosystems, Inc.. It received FDA 510(k) clearance on 1983-06-02 under 510(k) number K830871. The device is classified under product code HOC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHAKOSYSTEMS MODEL 1000/OMNI PACKS IRRIGATION/ASPIRATION?

PHAKOSYSTEMS MODEL 1000/OMNI PACKS IRRIGATION/ASPIRATION is a medical device that received FDA 510(k) clearance on 1983-06-02. The listed applicant is Phakosystems, Inc.. The 510(k) number is K830871.

When did PHAKOSYSTEMS MODEL 1000/OMNI PACKS IRRIGATION/ASPIRATION receive FDA 510(k) clearance?

PHAKOSYSTEMS MODEL 1000/OMNI PACKS IRRIGATION/ASPIRATION received FDA 510(k) clearance on 1983-06-02, under 510(k) number K830871.

Who is the listed applicant for PHAKOSYSTEMS MODEL 1000/OMNI PACKS IRRIGATION/ASPIRATION?

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

What is the FDA product code for PHAKOSYSTEMS MODEL 1000/OMNI PACKS IRRIGATION/ASPIRATION?

The FDA product code for PHAKOSYSTEMS MODEL 1000/OMNI PACKS IRRIGATION/ASPIRATION is HOC.

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 Phakosystems, 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.

K880081VISION CARE/PHAKOSYSTEMS ECHOPACHK871938VISION CARE/PHAKOSYSTEMS ECHORULEK860236PHAKOSYSTEMS CT-100 CAUTERY MODULEK851674PHAKOSYSTEMS MODEL CES 4100

Related Devices (Code: HOC)

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.

K871474PART #860070 ULTRAPAK & #860075 ULTRAPAKMedical Technical Products

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.

↑