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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 the device name listed in this FDA 510(k) record. The listed applicant is Apollo Endosurgery, Inc.. It received FDA 510(k) clearance on 2020-12-15 under 510(k) 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. The listed applicant is Apollo Endosurgery, Inc.. The 510(k) number is K201808.

When did X-Tack Endoscopic HeliX Tacking System receive FDA 510(k) clearance?

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

Who is the listed applicant for X-Tack Endoscopic HeliX Tacking System?

The FDA 510(k) record lists Apollo Endosurgery, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Apollo Endosurgery, 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.

K232544Apollo ESG NXT System, Apollo REVISE NXT SystemK231553OverStitch NXT Endoscopic Suturing SystemK210266OverStitch Sx Endoscopic Suturing SystemK191439OverStitch 2-0 Polypropylene SutureK181141OverStitch Endoscopic Suturing System and AccessoriesK171886OverStitch SX Endoscopic Suturing System (ESS)

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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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