FDA 510(k)

X-Tack Endoscopic HeliX Tacking System

K-번호: K201808 · 2020-12-15

결정일2020-12-15

제품 코드PKL

자문 위원회규제 정책: medical-regulatory-v1 GU

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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.

Apollo Endosurgery, Inc.를 신청인으로 등재한 기타 기록

K232544아폴로 ESG NXT 시스템, 아폴로 REVISE NXT 시스템 K231553OverStitch NXT Endoscopic Suturing System K210266OverStitch Sx Endoscopic Suturing System K171886OverStitch SX Endoscopic Suturing System (ESS)

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