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FDA 510(k)

14G CORMARK BIOPSY SITE IDENTIFIER

K-Number: K032217 · 2003-08-21

ApplicantArtemis Medical, Inc.
Decision Date2003-08-21
Product CodeFZP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

14G CORMARK BIOPSY SITE IDENTIFIER 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 2003-08-21 under 510(k) number K032217. 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 14G CORMARK BIOPSY SITE IDENTIFIER?

14G CORMARK BIOPSY SITE IDENTIFIER is a medical device that received FDA 510(k) clearance on 2003-08-21. The listed applicant is Artemis Medical, Inc.. The 510(k) number is K032217.

When did 14G CORMARK BIOPSY SITE IDENTIFIER receive FDA 510(k) clearance?

14G CORMARK BIOPSY SITE IDENTIFIER received FDA 510(k) clearance on 2003-08-21, under 510(k) number K032217.

Who is the listed applicant for 14G CORMARK BIOPSY SITE IDENTIFIER?

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 14G CORMARK BIOPSY SITE IDENTIFIER?

The FDA product code for 14G CORMARK BIOPSY SITE IDENTIFIER is FZP.

Related Clinical Trials

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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.

K020024CARIS MINITOME BIOPSY INSTRUMENTK003777CARIS SITE MARKER

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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