FDA 510(k)

GENERAL PURPOSE ATL NEEDLE GUIDE KIT

K-Number: K973958 · 1998-01-22

Decision Date1998-01-22

Product CodeITX

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

GENERAL PURPOSE ATL NEEDLE GUIDE KIT 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 1998-01-22 under 510(k) number K973958. 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 GENERAL PURPOSE ATL NEEDLE GUIDE KIT?

GENERAL PURPOSE ATL NEEDLE GUIDE KIT is a medical device that received FDA 510(k) clearance on 1998-01-22. The listed applicant is Protek Medical Products, Inc.. The 510(k) number is K973958.

When did GENERAL PURPOSE ATL NEEDLE GUIDE KIT receive FDA 510(k) clearance?

GENERAL PURPOSE ATL NEEDLE GUIDE KIT received FDA 510(k) clearance on 1998-01-22, under 510(k) number K973958.

Who is the listed applicant for GENERAL PURPOSE ATL NEEDLE GUIDE KIT?

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 GENERAL PURPOSE ATL NEEDLE GUIDE KIT?

The FDA product code for GENERAL PURPOSE ATL NEEDLE GUIDE KIT is ITX.

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Other records listing Protek Medical Products, Inc. as applicant

K973622TRANSDUCER POSITIONER K970889ULTRASOUND TRANSDUCER DRAPE K970893ULTRASOUND TRANSDUCER DRAPE K973362NEEDLE GUIDE/GRID K970885ULTRASOUND SYSTEMS DRAPE K970891DRAPE, SURGICAL-LATEX

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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.