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FDA 510(k)

BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818

K-Number: K081323 · 2008-07-22

ApplicantB-K Medical Aps
Decision Date2008-07-22
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818 is the device name listed in this FDA 510(k) record. The listed applicant is B-K Medical Aps. It received FDA 510(k) clearance on 2008-07-22 under 510(k) number K081323. The device is classified under product code FCG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818?

BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818 is a medical device that received FDA 510(k) clearance on 2008-07-22. The listed applicant is B-K Medical Aps. The 510(k) number is K081323.

When did BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818 receive FDA 510(k) clearance?

BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818 received FDA 510(k) clearance on 2008-07-22, under 510(k) number K081323.

Who is the listed applicant for BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818?

The FDA 510(k) record lists B-K Medical Aps as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818?

The FDA product code for BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818 is FCG.

Related Clinical Trials

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Other records listing B-K Medical Aps 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.

K123254ULTRASOUND SCANNER FLEX FOCUSK100919PRO FOCUS 2202, PRO FOCUS 2202 UV MODEL: TYPE 2202K083667NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336, NEEDLE GUIDE FOR 8824, MODEL UA 1337K081154ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202K070077ULTRASOUND SCANNER PROFOCUS, MODEL 2202

Related Devices (Code: FCG)

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.

K252646Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)Olympus Medical Systems Corp.K250994ClearTip FNA and FNB TypesFinemedix Co., Ltd.K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)Cook Ireland, Ltd.K231422Precision GILimaca Medical, Ltd.K231267ClearTipFinemedix Co., Ltd.K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, Ltd.

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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