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FDA 510(k)

SMARTGUIDE

K-Number: K963894 · 1997-03-11

ApplicantFerguson Medical
Decision Date1997-03-11
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SMARTGUIDE is the device name listed in this FDA 510(k) record. The listed applicant is Ferguson Medical. It received FDA 510(k) clearance on 1997-03-11 under 510(k) number K963894. 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 SMARTGUIDE?

SMARTGUIDE is a medical device that received FDA 510(k) clearance on 1997-03-11. The listed applicant is Ferguson Medical. The 510(k) number is K963894.

When did SMARTGUIDE receive FDA 510(k) clearance?

SMARTGUIDE received FDA 510(k) clearance on 1997-03-11, under 510(k) number K963894.

Who is the listed applicant for SMARTGUIDE?

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

What is the FDA product code for SMARTGUIDE?

The FDA product code for SMARTGUIDE is FCG.

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Other records listing Ferguson Medical 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.

K033153DICOM THEATERK963794PUNCTURENEEDLEK962615TUMORLOCALIZER MRIK971813EMBLAK972217ORTHOPEDIC SCREW SYSTEMK972219ORTHOPEDIC PLATE SYSTEM

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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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