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)

ANDREWS INTRODUCER, MODEL ASI01

K-Number: K023173 · 2002-12-18

ApplicantAndrews Surgical Innovations, Ltd.
Decision Date2002-12-18
Product CodeMDM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ANDREWS INTRODUCER, MODEL ASI01 is the device name listed in this FDA 510(k) record. The listed applicant is Andrews Surgical Innovations, Ltd.. It received FDA 510(k) clearance on 2002-12-18 under 510(k) number K023173. The device is classified under product code MDM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANDREWS INTRODUCER, MODEL ASI01?

ANDREWS INTRODUCER, MODEL ASI01 is a medical device that received FDA 510(k) clearance on 2002-12-18. The listed applicant is Andrews Surgical Innovations, Ltd.. The 510(k) number is K023173.

When did ANDREWS INTRODUCER, MODEL ASI01 receive FDA 510(k) clearance?

ANDREWS INTRODUCER, MODEL ASI01 received FDA 510(k) clearance on 2002-12-18, under 510(k) number K023173.

Who is the listed applicant for ANDREWS INTRODUCER, MODEL ASI01?

The FDA 510(k) record lists Andrews Surgical Innovations, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANDREWS INTRODUCER, MODEL ASI01?

The FDA product code for ANDREWS INTRODUCER, MODEL ASI01 is MDM.

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

Related Devices (Code: MDM)

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.

K073664FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCERInjectimed, Inc.K050575FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEMFutumeds Sdn BhdK050957EUTROCHARSpecial Devices, Inc.K022059MICROVASIVE PULMONARY GUIDEWIREBoston Scientific CorpK013040LIGHT SABER INTRODUCER NEEDLEMinrad, Inc.K010184CHESS HAND SURGERY SYSTEMCanica Design, 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.

↑