FDA 510(k)

Zimmon Needle Knife Papillotome

K-번호: K171993 · 2017-08-17

신청자Wilson-Cook Medical Inc./Cook Endoscopy

결정일2017-08-17

제품 코드KNS

자문 위원회GU

결정Substantially Equivalent

기기 요약

Zimmon Needle Knife Papillotome is the device name listed in this FDA 510(k) record. The listed applicant is Wilson-Cook Medical Inc./Cook Endoscopy. It received FDA 510(k) clearance on 2017-08-17 under 510(k) number K171993. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Zimmon Needle Knife Papillotome?

Zimmon Needle Knife Papillotome is a medical device that received FDA 510(k) clearance on 2017-08-17. The listed applicant is Wilson-Cook Medical Inc./Cook Endoscopy. The 510(k) number is K171993.

When did Zimmon Needle Knife Papillotome receive FDA 510(k) clearance?

Zimmon Needle Knife Papillotome received FDA 510(k) clearance on 2017-08-17, under 510(k) number K171993.

Who is the listed applicant for Zimmon Needle Knife Papillotome?

The FDA 510(k) record lists Wilson-Cook Medical Inc./Cook Endoscopy as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Zimmon Needle Knife Papillotome?

The FDA product code for Zimmon Needle Knife Papillotome is KNS.

Wilson-Cook Medical Inc./Cook Endoscopy를 신청인으로 등재한 기타 기록

K190829Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)K172665Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cords K172288Fusion OMNI Sphincterotome K171607Bronchi and Gastrointestinal Cytology Brush

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.