FDA 510(k)

Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis

K-번호: K182272 · 2019-04-15

결정일2019-04-15

제품 코드NLQ

결정Substantially Equivalent

기기 요약

Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis is the device name listed in this FDA 510(k) record. The listed applicant is Sterilmed, Inc.. It received FDA 510(k) clearance on 2019-04-15 under 510(k) number K182272. The device is classified under product code NLQ. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis?

Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis is a medical device that received FDA 510(k) clearance on 2019-04-15. The listed applicant is Sterilmed, Inc.. The 510(k) number is K182272.

When did Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis receive FDA 510(k) clearance?

Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis received FDA 510(k) clearance on 2019-04-15, under 510(k) number K182272.

Who is the listed applicant for Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis?

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

What is the FDA product code for Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis?

The FDA product code for Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis is NLQ.

Sterilmed, Inc.를 신청인으로 등재한 기타 기록

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