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FDA 510(k)

X-Tack Endoscopic HeliX Tacking System

K-Number: K201808 · 2020-12-15

ApplicantApollo Endosurgery, Inc.
Decision Date2020-12-15
Product CodePKL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

X-Tack Endoscopic HeliX Tacking System is a medical device manufactured by Apollo Endosurgery, Inc.. It received FDA 510(k) clearance on 2020-12-15 under approval number K201808. 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 X-Tack Endoscopic HeliX Tacking System?

X-Tack Endoscopic HeliX Tacking System is a medical device that received FDA 510(k) clearance on 2020-12-15. It is manufactured by Apollo Endosurgery, Inc.. The 510(k) number is K201808.

When was X-Tack Endoscopic HeliX Tacking System approved by the FDA?

X-Tack Endoscopic HeliX Tacking System received FDA 510(k) clearance on 2020-12-15, under approval number K201808.

What company makes X-Tack Endoscopic HeliX Tacking System?

X-Tack Endoscopic HeliX Tacking System is manufactured by Apollo Endosurgery, Inc..

What is the FDA product code for X-Tack Endoscopic HeliX Tacking System?

The FDA product code for X-Tack Endoscopic HeliX Tacking System is PKL.

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Other Devices by Apollo Endosurgery, Inc.

K171886OverStitch SX Endoscopic Suturing System (ESS) K210266OverStitch Sx Endoscopic Suturing System DEN210045APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System K232544Apollo ESG NXT System, Apollo REVISE NXT System K231553OverStitch NXT Endoscopic Suturing System

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.

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