FDA 510(k)

stentfix OTSC System Set

K-Number: K183309 · 2019-10-22

Decision Date2019-10-22

Product CodePKL

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

stentfix OTSC System Set is a medical device manufactured by Ovesco Endoscopy AG. It received FDA 510(k) clearance on 2019-10-22 under approval number K183309. 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 stentfix OTSC System Set?

stentfix OTSC System Set is a medical device that received FDA 510(k) clearance on 2019-10-22. It is manufactured by Ovesco Endoscopy AG. The 510(k) number is K183309.

When was stentfix OTSC System Set approved by the FDA?

stentfix OTSC System Set received FDA 510(k) clearance on 2019-10-22, under approval number K183309.

What company makes stentfix OTSC System Set?

stentfix OTSC System Set is manufactured by Ovesco Endoscopy AG.

What is the FDA product code for stentfix OTSC System Set?

The FDA product code for stentfix OTSC System Set is PKL.

Other Devices by Ovesco Endoscopy AG

K153550FTRD System Set DEN160014remOVE System K170867FTRD System Set K200684gastroduodenal FTRD Set K221385LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02) K241858BARS Set (100.60)

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Related Devices (Code: PKL)

K153550FTRD System SetOvesco Endoscopy AG K170867FTRD System SetOvesco Endoscopy AG K161463SureClip(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd. K182556SureClip Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd. K180325Single Use MultiClip DeviceMicro-Tech (Nanjing) Co., Ltd. K172727HemoclipHangzhou 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.