FDA 510(k)

X-Tack Endoscopic HeliX Tacking System

N.º K: K201808 · 2020-12-15

Fecha de decisión2020-12-15

Código de productoPKL

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

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Otros registros que enlistan a Apollo Endosurgery, Inc. como solicitante

K232544Sistema Apollo ESG NXT, Sistema Apollo REVISE NXT K231553OverStitch NXT Endoscopic Suturing System K210266OverStitch Sx Endoscopic Suturing System K171886OverStitch SX Endoscopic Suturing System (ESS)

Dispositivos relacionados (Código: PKL)

K253481colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72)Ovesco Endoscopy AG 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 Endoscopy K251562OTSCneo System Set (100.03n-14n, 100.27n-31n)Ovesco Endoscopy AG

Fuente oficial

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