FDA 510(k)

UNIDRIVE SIII System

K-번호: K223520 · 2023-04-27

결정일2023-04-27

제품 코드HIH

자문 위원회OB

결정Substantially Equivalent

기기 요약

UNIDRIVE SIII System is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz-Endoscopy-America, Inc.. It received FDA 510(k) clearance on 2023-04-27 under 510(k) number K223520. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the UNIDRIVE SIII System?

UNIDRIVE SIII System is a medical device that received FDA 510(k) clearance on 2023-04-27. The listed applicant is Karl Storz-Endoscopy-America, Inc.. The 510(k) number is K223520.

When did UNIDRIVE SIII System receive FDA 510(k) clearance?

UNIDRIVE SIII System received FDA 510(k) clearance on 2023-04-27, under 510(k) number K223520.

Who is the listed applicant for UNIDRIVE SIII System?

The FDA 510(k) record lists Karl Storz-Endoscopy-America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNIDRIVE SIII System?

The FDA product code for UNIDRIVE SIII System is HIH.

Karl Storz-Endoscopy-America, Inc.를 신청인으로 등재한 기타 기록

K252624KARL STORZ Laryngoscopes and Accessories K240506KARL STORZ Holders K223885HOPKINS Telescopes K230359KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER-K223923HOPKINS Telescopes K221893KARL STORZ Bipolar Resectoscopes with HF Cable

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