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FDA 510(k)

PROTECTISCOPE CS COLONOSCOPE, NON-INTRAPULL

K-Number: K081004 · 2008-05-02

ApplicantStryker GI
Decision Date2008-05-02
Product CodeFDF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PROTECTISCOPE CS COLONOSCOPE, NON-INTRAPULL is the device name listed in this FDA 510(k) record. The listed applicant is Stryker GI. It received FDA 510(k) clearance on 2008-05-02 under 510(k) number K081004. 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 PROTECTISCOPE CS COLONOSCOPE, NON-INTRAPULL?

PROTECTISCOPE CS COLONOSCOPE, NON-INTRAPULL is a medical device that received FDA 510(k) clearance on 2008-05-02. The listed applicant is Stryker GI. The 510(k) number is K081004.

When did PROTECTISCOPE CS COLONOSCOPE, NON-INTRAPULL receive FDA 510(k) clearance?

PROTECTISCOPE CS COLONOSCOPE, NON-INTRAPULL received FDA 510(k) clearance on 2008-05-02, under 510(k) number K081004.

Who is the listed applicant for PROTECTISCOPE CS COLONOSCOPE, NON-INTRAPULL?

The FDA 510(k) record lists Stryker GI as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROTECTISCOPE CS COLONOSCOPE, NON-INTRAPULL?

The FDA product code for PROTECTISCOPE CS COLONOSCOPE, NON-INTRAPULL is FDF.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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