FDA 510(k)

GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter

K-번호: K213283 · 2022-06-22

결정일2022-06-22

제품 코드GBM

자문 위원회GU

결정Substantially Equivalent

기기 요약

GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Convatec Limited. It received FDA 510(k) clearance on 2022-06-22 under 510(k) number K213283. The device is classified under product code GBM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter?

GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter is a medical device that received FDA 510(k) clearance on 2022-06-22. The listed applicant is Convatec Limited. The 510(k) number is K213283.

When did GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter receive FDA 510(k) clearance?

GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter received FDA 510(k) clearance on 2022-06-22, under 510(k) number K213283.

Who is the listed applicant for GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter?

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

What is the FDA product code for GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter?

The FDA product code for GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter is GBM.

Convatec Limited를 신청인으로 등재한 기타 기록

K252943GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women K250891Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C K190114Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)K180205AVELLE 부정압 상처 치료 시스템 K181206GentleCath Glide Intermittent Urinary Catheter K173675AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber

10개 장치 모두 보기 →

공식 출처

FDA 데이터베이스에서 보기 →

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