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FDA 510(k)

FTRD System Set

K-Number: K153550 · 2016-10-12

ApplicantOvesco Endoscopy AG
Decision Date2016-10-12
Product CodePKL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FTRD System Set is the device name listed in this FDA 510(k) record. The listed applicant is Ovesco Endoscopy AG. It received FDA 510(k) clearance on 2016-10-12 under 510(k) number K153550. The device is classified under product code PKL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FTRD System Set?

FTRD System Set is a medical device that received FDA 510(k) clearance on 2016-10-12. The listed applicant is Ovesco Endoscopy AG. The 510(k) number is K153550.

When did FTRD System Set receive FDA 510(k) clearance?

FTRD System Set received FDA 510(k) clearance on 2016-10-12, under 510(k) number K153550.

Who is the listed applicant for FTRD System Set?

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

What is the FDA product code for FTRD System Set?

The FDA product code for FTRD System Set is PKL.

Other records listing Ovesco Endoscopy AG 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.

K251562OTSCneo System Set (100.03n-14n, 100.27n-31n)K242586ArgoCap (200.52)K241858BARS Set (100.60)K221385LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)K200684gastroduodenal FTRD SetK183309stentfix OTSC System Set

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Related Devices (Code: PKL)

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.

K254069Hemoclip (511 series, 543 series)Hangzhou AGS MedTech Co., Ltd.K260580Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)Olympus Medical Systems Corp.K252270HemoclipHangzhou AGS MedTech Co., Ltd.K253734Taurus ClipTaurus EndoscopyK251562OTSCneo System Set (100.03n-14n, 100.27n-31n)Ovesco Endoscopy AGK252271HemoclipHangzhou AGS MedTech 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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