FDA 510(k)

SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230)

K-번호: K242923 · 2024-12-20

결정일2024-12-20

제품 코드OCZ

자문 위원회GU

결정Substantially Equivalent

기기 요약

SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230) is the device name listed in this FDA 510(k) record. The listed applicant is Envision Endoscopy. It received FDA 510(k) clearance on 2024-12-20 under 510(k) number K242923. The device is classified under product code OCZ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230)?

SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230) is a medical device that received FDA 510(k) clearance on 2024-12-20. The listed applicant is Envision Endoscopy. The 510(k) number is K242923.

When did SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230) receive FDA 510(k) clearance?

SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230) received FDA 510(k) clearance on 2024-12-20, under 510(k) number K242923.

Who is the listed applicant for SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230)?

The FDA 510(k) record lists Envision Endoscopy as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230)?

The FDA product code for SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230) is OCZ.

Envision Endoscopy를 신청인으로 등재한 기타 기록

K243750SimpleStitch Suturing System

공식 출처

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