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FDA 510(k)

BIOPSY SCIENCES, LLC. MAXI-CELL BIOPSY NEEDLES

K-Number: K021847 · 2002-09-03

ApplicantBiopsy Sciences, LLC
Decision Date2002-09-03
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BIOPSY SCIENCES, LLC. MAXI-CELL BIOPSY NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Biopsy Sciences, LLC. It received FDA 510(k) clearance on 2002-09-03 under 510(k) number K021847. 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 SCIENCES, LLC. MAXI-CELL BIOPSY NEEDLES?

BIOPSY SCIENCES, LLC. MAXI-CELL BIOPSY NEEDLES is a medical device that received FDA 510(k) clearance on 2002-09-03. The listed applicant is Biopsy Sciences, LLC. The 510(k) number is K021847.

When did BIOPSY SCIENCES, LLC. MAXI-CELL BIOPSY NEEDLES receive FDA 510(k) clearance?

BIOPSY SCIENCES, LLC. MAXI-CELL BIOPSY NEEDLES received FDA 510(k) clearance on 2002-09-03, under 510(k) number K021847.

Who is the listed applicant for BIOPSY SCIENCES, LLC. MAXI-CELL BIOPSY NEEDLES?

The FDA 510(k) record lists Biopsy Sciences, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOPSY SCIENCES, LLC. MAXI-CELL BIOPSY NEEDLES?

The FDA product code for BIOPSY SCIENCES, LLC. MAXI-CELL BIOPSY NEEDLES is FCG.

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Other records listing Biopsy Sciences, LLC 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.

K130537BIOPSY SCIENCES LLC HYDROMARK BREAST BIOPSY SITE MARKERK121113BIOPSY SCIENCES, INC. HYDROMARK BREST BIOSY SITE MARKERK090501BIOPSY SCIENCES HYDROMARK BREAST BIOPSY SITE MARKER, MODELS 4005-02-15-T1, 4005-02-15-S1, 4005-03-15-T1, 4005-03-15-S1K083006BIOPSY SCIENCES, INC., HYDROMARK BREAST BIOPSY SITE MARKERK060769HYDROMARK BIOPSY SITE MARKERK041331BIOPSY SCIENCES, LLC, LUNG BIOPSY SITE MARKER

View all 8 devices →

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

View on FDA Database →

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

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