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)

CARIS SITE MARKER

K-Number: K003777 · 2001-03-06

ApplicantArtemis Medical, Inc.
Decision Date2001-03-06
Product CodeFZP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CARIS SITE MARKER is the device name listed in this FDA 510(k) record. The listed applicant is Artemis Medical, Inc.. It received FDA 510(k) clearance on 2001-03-06 under 510(k) number K003777. The device is classified under product code FZP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARIS SITE MARKER?

CARIS SITE MARKER is a medical device that received FDA 510(k) clearance on 2001-03-06. The listed applicant is Artemis Medical, Inc.. The 510(k) number is K003777.

When did CARIS SITE MARKER receive FDA 510(k) clearance?

CARIS SITE MARKER received FDA 510(k) clearance on 2001-03-06, under 510(k) number K003777.

Who is the listed applicant for CARIS SITE MARKER?

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

What is the FDA product code for CARIS SITE MARKER?

The FDA product code for CARIS SITE MARKER is FZP.

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 Artemis Medical, 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.

K03221714G CORMARK BIOPSY SITE IDENTIFIERK020024CARIS MINITOME BIOPSY INSTRUMENT

Related Devices (Code: FZP)

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.

K260677Vessel Closure Device (VCD177213P)Vcd Medical S.R.L.K254231Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating ClipsTaiwan Surgical CorporationK253781InnoClip Clip ApplierTaiwan Surgical CorporationK253903InnoClip Disposable Clip ApplierTaiwan Surgical CorporationK250643Disposable Polymer Ligation ClipsHangzhou Kangji Medical Instrument Co., Ltd.K251054Hem-o-lok™ PurplePlus™ Large Polymer Ligating ClipsTeleflex Medical

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.

↑