FDA 510(k)

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K-번호: K163435 · 2017-04-05

결정일2017-04-05

제품 코드BSP

자문 위원회안내: 의료기기 규제 문서 번역 요청입니다. 회사명, 제품명, FDA, 510(k), PMA, NCT, PMID, 식별자 및 URL을 보존하여 번역하여 주세요. 정책: 의료규제-v1. [원문] AN [번역] 안내

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기기 요약

Entellus Medical Reinforced Anesthesia Needle is the device name listed in this FDA 510(k) record. The listed applicant is Entellus Medical, Inc.. It received FDA 510(k) clearance on 2017-04-05 under 510(k) number K163435. The device is classified under product code BSP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Entellus Medical Reinforced Anesthesia Needle?

Entellus Medical Reinforced Anesthesia Needle is a medical device that received FDA 510(k) clearance on 2017-04-05. The listed applicant is Entellus Medical, Inc.. The 510(k) number is K163435.

When did Entellus Medical Reinforced Anesthesia Needle receive FDA 510(k) clearance?

Entellus Medical Reinforced Anesthesia Needle received FDA 510(k) clearance on 2017-04-05, under 510(k) number K163435.

Who is the listed applicant for Entellus Medical Reinforced Anesthesia Needle?

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

What is the FDA product code for Entellus Medical Reinforced Anesthesia Needle?

The FDA product code for Entellus Medical Reinforced Anesthesia Needle is BSP.

Entellus Medical, Inc.를 신청인으로 등재한 기타 기록

K220027오디언 ET 확장 시스템 K163509XprESS ENT Dilation System

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