FDA 510(k)

미네소타 메디칼 테크놀로지즈 대변 incontience 삽입기 (마이 미라클)

K-번호: K243367 · 2025-07-22

결정일2025-07-22

제품 코드PBP

자문 위원회규제 정책: medical-regulatory-v1 GU

결정Substantially Equivalent

기기 요약

Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle) is the device name listed in this FDA 510(k) record. The listed applicant is Minnesota Medical Technologies. It received FDA 510(k) clearance on 2025-07-22 under 510(k) number K243367. The device is classified under product code PBP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle)?

Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle) is a medical device that received FDA 510(k) clearance on 2025-07-22. The listed applicant is Minnesota Medical Technologies. The 510(k) number is K243367.

When did Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle) receive FDA 510(k) clearance?

Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle) received FDA 510(k) clearance on 2025-07-22, under 510(k) number K243367.

Who is the listed applicant for Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle)?

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

What is the FDA product code for Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle)?

The FDA product code for Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle) is PBP.

공식 출처

FDA 데이터베이스에서 보기 →

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

기기 요약

자주 묻는 질문

관련 임상시험

공식 출처