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)

ISCIENCE SURGICAL VISCOINJECTOR

K-Number: K050716 · 2005-04-21

ApplicantIscience Surgical Corporation
Decision Date2005-04-21
Product CodeMRH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ISCIENCE SURGICAL VISCOINJECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Iscience Surgical Corporation. It received FDA 510(k) clearance on 2005-04-21 under 510(k) number K050716. The device is classified under product code MRH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISCIENCE SURGICAL VISCOINJECTOR?

ISCIENCE SURGICAL VISCOINJECTOR is a medical device that received FDA 510(k) clearance on 2005-04-21. The listed applicant is Iscience Surgical Corporation. The 510(k) number is K050716.

When did ISCIENCE SURGICAL VISCOINJECTOR receive FDA 510(k) clearance?

ISCIENCE SURGICAL VISCOINJECTOR received FDA 510(k) clearance on 2005-04-21, under 510(k) number K050716.

Who is the listed applicant for ISCIENCE SURGICAL VISCOINJECTOR?

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

What is the FDA product code for ISCIENCE SURGICAL VISCOINJECTOR?

The FDA product code for ISCIENCE SURGICAL VISCOINJECTOR is MRH.

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 Iscience Surgical Corporation 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.

K041108ISCIENCE SURGICAL OPHTHALMIC MICROCANNULA

Related Devices (Code: MRH)

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.

K253760OMNI Ultra Surgical System (1-110)Sight Sciences, Inc.K243503VIA360™ Surgical SystemNew World Medical, Inc.K232214OMNI Surgical SystemSight Sciences, Inc.K213173TrabEx ProMicrosurgical Technologies, Inc.K212797iPrime Viscodelivery SystemGlaukosK211680Streamline Surgical SystemNew World Medical, Inc.

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.

↑