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FDA 510(k)

HIGH SPEED CORE CUT BIOPSY GUN

K-Number: K905556 · 1991-03-08

ApplicantUni-Quatro Industries Canada, Inc.
Decision Date1991-03-08
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HIGH SPEED CORE CUT BIOPSY GUN is the device name listed in this FDA 510(k) record. The listed applicant is Uni-Quatro Industries Canada, Inc.. It received FDA 510(k) clearance on 1991-03-08 under 510(k) number K905556. 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 HIGH SPEED CORE CUT BIOPSY GUN?

HIGH SPEED CORE CUT BIOPSY GUN is a medical device that received FDA 510(k) clearance on 1991-03-08. The listed applicant is Uni-Quatro Industries Canada, Inc.. The 510(k) number is K905556.

When did HIGH SPEED CORE CUT BIOPSY GUN receive FDA 510(k) clearance?

HIGH SPEED CORE CUT BIOPSY GUN received FDA 510(k) clearance on 1991-03-08, under 510(k) number K905556.

Who is the listed applicant for HIGH SPEED CORE CUT BIOPSY GUN?

The FDA 510(k) record lists Uni-Quatro Industries Canada, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HIGH SPEED CORE CUT BIOPSY GUN?

The FDA product code for HIGH SPEED CORE CUT BIOPSY GUN is FCG.

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.

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Other records listing Uni-Quatro Industries Canada, 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.

K915801BIP-COAX-SYSTEMK905557CCC CROWN-CORE-CUT-NEEDLE

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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