FDA 510(k)

SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL NUMBERS BASED ON TRANSDUCER AND COVER)

K-Number: K043425 · 2005-02-28

Decision Date2005-02-28

Product CodeITX

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL NUMBERS BASED ON TRANSDUCER AND COVER) is the device name listed in this FDA 510(k) record. The listed applicant is Sheathing Technologies, Inc.. It received FDA 510(k) clearance on 2005-02-28 under 510(k) number K043425. 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 SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL NUMBERS BASED ON TRANSDUCER AND COVER)?

SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL NUMBERS BASED ON TRANSDUCER AND COVER) is a medical device that received FDA 510(k) clearance on 2005-02-28. The listed applicant is Sheathing Technologies, Inc.. The 510(k) number is K043425.

When did SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL NUMBERS BASED ON TRANSDUCER AND COVER) receive FDA 510(k) clearance?

SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL NUMBERS BASED ON TRANSDUCER AND COVER) received FDA 510(k) clearance on 2005-02-28, under 510(k) number K043425.

Who is the listed applicant for SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL NUMBERS BASED ON TRANSDUCER AND COVER)?

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

What is the FDA product code for SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL NUMBERS BASED ON TRANSDUCER AND COVER)?

The FDA product code for SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL NUMBERS BASED ON TRANSDUCER AND COVER) is ITX.

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Other records listing Sheathing Technologies, Inc. as applicant

K153212Sheathes Ultrasound Probe Covers K130041SHEATHES STERILE ULTRASOUND GEL K112827SHEATHES ULTRASOND GEL K100966COLONOSCOPE/SIGMOIDOSCOPE SHEATHES K091828SHEATHESISO ULTRASOUND TRANSDUCER COVER K990175SHEATHES (NON-LATEX), STERILE

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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.