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FDA 510(k)

BIP-COAX-SYSTEM

K-Number: K915801 · 1994-03-11

ApplicantUni-Quatro Industries Canada, Inc.
Decision Date1994-03-11
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BIP-COAX-SYSTEM 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 1994-03-11 under 510(k) number K915801. 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 BIP-COAX-SYSTEM?

BIP-COAX-SYSTEM is a medical device that received FDA 510(k) clearance on 1994-03-11. The listed applicant is Uni-Quatro Industries Canada, Inc.. The 510(k) number is K915801.

When did BIP-COAX-SYSTEM receive FDA 510(k) clearance?

BIP-COAX-SYSTEM received FDA 510(k) clearance on 1994-03-11, under 510(k) number K915801.

Who is the listed applicant for BIP-COAX-SYSTEM?

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 BIP-COAX-SYSTEM?

The FDA product code for BIP-COAX-SYSTEM 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.

K905556HIGH SPEED CORE CUT BIOPSY GUNK905557CCC 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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