FDA 510(k)

내시경 적용기, 41 cm

K-번호: K241739 · 2024-07-15

결정일2024-07-15

제품 코드GCJ

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

Endoscopic Applicator, 41 cm is the device name listed in this FDA 510(k) record. The listed applicant is Micromedics, Inc.. It received FDA 510(k) clearance on 2024-07-15 under 510(k) number K241739. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Endoscopic Applicator, 41 cm?

Endoscopic Applicator, 41 cm is a medical device that received FDA 510(k) clearance on 2024-07-15. The listed applicant is Micromedics, Inc.. The 510(k) number is K241739.

When did Endoscopic Applicator, 41 cm receive FDA 510(k) clearance?

Endoscopic Applicator, 41 cm received FDA 510(k) clearance on 2024-07-15, under 510(k) number K241739.

Who is the listed applicant for Endoscopic Applicator, 41 cm?

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

What is the FDA product code for Endoscopic Applicator, 41 cm?

The FDA product code for Endoscopic Applicator, 41 cm is GCJ.

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내시경 적용기, 41 cm

기기 요약

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관련 임상시험

관련 기기 (코드: GCJ)

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