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FDA 510(k)

SHEATHES (NON-LATEX), STERILE

K-Number: K990175 · 1999-04-21

ApplicantSheathing Technologies, Inc.
Decision Date1999-04-21
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SHEATHES (NON-LATEX), STERILE 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 1999-04-21 under 510(k) number K990175. 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 (NON-LATEX), STERILE?

SHEATHES (NON-LATEX), STERILE is a medical device that received FDA 510(k) clearance on 1999-04-21. The listed applicant is Sheathing Technologies, Inc.. The 510(k) number is K990175.

When did SHEATHES (NON-LATEX), STERILE receive FDA 510(k) clearance?

SHEATHES (NON-LATEX), STERILE received FDA 510(k) clearance on 1999-04-21, under 510(k) number K990175.

Who is the listed applicant for SHEATHES (NON-LATEX), STERILE?

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 (NON-LATEX), STERILE?

The FDA product code for SHEATHES (NON-LATEX), STERILE is ITX.

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Other records listing Sheathing Technologies, 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.

K153212Sheathes Ultrasound Probe CoversK130041SHEATHES STERILE ULTRASOUND GELK112827SHEATHES ULTRASOND GELK100966COLONOSCOPE/SIGMOIDOSCOPE SHEATHESK091828SHEATHESISO ULTRASOUND TRANSDUCER COVERK043425SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL NUMBERS BASED ON TRANSDUCER AND COVER)

View all 7 devices →

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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