FDA 510(k)

GE MEDICAL-NEEDLE GUIDE FOR SV, TR ANDATF, ACUSON-NEEDLE GUIDE

K-Number: K971115 · 1997-06-13

Decision Date1997-06-13

Product CodeITX

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

GE MEDICAL-NEEDLE GUIDE FOR SV, TR ANDATF, ACUSON-NEEDLE GUIDE is the device name listed in this FDA 510(k) record. The listed applicant is Protek Medical Products, Inc.. It received FDA 510(k) clearance on 1997-06-13 under 510(k) number K971115. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GE MEDICAL-NEEDLE GUIDE FOR SV, TR ANDATF, ACUSON-NEEDLE GUIDE?

GE MEDICAL-NEEDLE GUIDE FOR SV, TR ANDATF, ACUSON-NEEDLE GUIDE is a medical device that received FDA 510(k) clearance on 1997-06-13. The listed applicant is Protek Medical Products, Inc.. The 510(k) number is K971115.

When did GE MEDICAL-NEEDLE GUIDE FOR SV, TR ANDATF, ACUSON-NEEDLE GUIDE receive FDA 510(k) clearance?

GE MEDICAL-NEEDLE GUIDE FOR SV, TR ANDATF, ACUSON-NEEDLE GUIDE received FDA 510(k) clearance on 1997-06-13, under 510(k) number K971115.

Who is the listed applicant for GE MEDICAL-NEEDLE GUIDE FOR SV, TR ANDATF, ACUSON-NEEDLE GUIDE?

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

What is the FDA product code for GE MEDICAL-NEEDLE GUIDE FOR SV, TR ANDATF, ACUSON-NEEDLE GUIDE?

The FDA product code for GE MEDICAL-NEEDLE GUIDE FOR SV, TR ANDATF, ACUSON-NEEDLE GUIDE is ITX.

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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 Protek Medical Products, Inc. as applicant

K973958GENERAL PURPOSE ATL NEEDLE GUIDE KIT K973622TRANSDUCER POSITIONER K970893ULTRASOUND TRANSDUCER DRAPE K970889ULTRASOUND TRANSDUCER DRAPE K973362NEEDLE GUIDE/GRID K970885ULTRASOUND SYSTEMS DRAPE

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Related Devices (Code: ITX)

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm Corporation K254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLC K261014Accuro® 3S Needle Guide KitRivanna Medical, Inc.

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.