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FDA 510(k)

NEEDLE GUIDE/GRID

K-Number: K973362 · 1997-10-01

ApplicantProtek Medical Products, Inc.
Decision Date1997-10-01
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NEEDLE GUIDE/GRID 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 1997-10-01 under 510(k) number K973362. 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 NEEDLE GUIDE/GRID?

NEEDLE GUIDE/GRID is a medical device that received FDA 510(k) clearance on 1997-10-01. The listed applicant is Protek Medical Products, Inc.. The 510(k) number is K973362.

When did NEEDLE GUIDE/GRID receive FDA 510(k) clearance?

NEEDLE GUIDE/GRID received FDA 510(k) clearance on 1997-10-01, under 510(k) number K973362.

Who is the listed applicant for NEEDLE GUIDE/GRID?

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 NEEDLE GUIDE/GRID?

The FDA product code for NEEDLE GUIDE/GRID 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

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.

K973958GENERAL PURPOSE ATL NEEDLE GUIDE KITK973622TRANSDUCER POSITIONERK970893ULTRASOUND TRANSDUCER DRAPEK970889ULTRASOUND TRANSDUCER DRAPEK970885ULTRASOUND SYSTEMS DRAPEK970891DRAPE, SURGICAL-LATEX

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Related Devices (Code: ITX)

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.

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 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.

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