FDA 510(k)

UNIDRIVE SIII System

N.º K: K223520 · 2023-04-27

SolicitanteKarl Storz-Endoscopy-America, Inc.

Fecha de decisión2023-04-27

Código de productoHIH

Comité asesorOB

DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

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Otros registros que enlistan a Karl Storz-Endoscopy-America, Inc. como solicitante

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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Dispositivos relacionados (Código: HIH)

K254252UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10)Karl Storz SE & CO. KG K261102UNIDRIVE Select SystemKarl Storz SE & CO. KG K254294Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A 14.4- 0, GYUT-A 14.4- 12,GYUT-A 14.4- 22, GYUT-A 14.4- 30, GYUT-B 15- 0, GYUT-B 15- 12, GYUT-B 15-22, GYUT-B 15- 30)Zhejiang Geyi Medical Instrument Co., Ltd.K260984HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)Axora Medical, Inc.K253020Strauss Surgical Resection InstrumentsAmerican Medical Endoscopy, Inc.K254050Manual Tissue Removal DeviceSuzhou AcuVu Medical Technology Co., Ltd.

Fuente oficial

Ver en la base de datos de la FDA →

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