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FDA 510(k)

COLONOSCOPE/SIGMOIDOSCOPE SHEATHES

K-Number: K100966 · 2010-08-03

ApplicantSheathing Technologies, Inc.
Decision Date2010-08-03
Product CodeFDF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COLONOSCOPE/SIGMOIDOSCOPE SHEATHES 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 2010-08-03 under 510(k) number K100966. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLONOSCOPE/SIGMOIDOSCOPE SHEATHES?

COLONOSCOPE/SIGMOIDOSCOPE SHEATHES is a medical device that received FDA 510(k) clearance on 2010-08-03. The listed applicant is Sheathing Technologies, Inc.. The 510(k) number is K100966.

When did COLONOSCOPE/SIGMOIDOSCOPE SHEATHES receive FDA 510(k) clearance?

COLONOSCOPE/SIGMOIDOSCOPE SHEATHES received FDA 510(k) clearance on 2010-08-03, under 510(k) number K100966.

Who is the listed applicant for COLONOSCOPE/SIGMOIDOSCOPE SHEATHES?

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 COLONOSCOPE/SIGMOIDOSCOPE SHEATHES?

The FDA product code for COLONOSCOPE/SIGMOIDOSCOPE SHEATHES is FDF.

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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 GELK091828SHEATHESISO ULTRASOUND TRANSDUCER COVERK043425SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL NUMBERS BASED ON TRANSDUCER AND COVER)K990175SHEATHES (NON-LATEX), STERILE

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Related Devices (Code: FDF)

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.

K260503Triton 1 SystemNeptune Medical, Inc.K261015Solo Scope Colonoscope SystemGi View, Ltd.K261587Insufflation Retention Device (IRD) (11173-325-101)BPEndo, LLCK260423Disposable Endoscopic Distal AttachmentsYangzhou Fartley Medical Instrument Technology Co., Ltd.K252457Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co., Ltd.K244029ROBOPERA (ER-R-002); ROBOPERA (ER-R-003)Endorobotics Co., Ltd.

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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