FDA 510(k)

HOPKINS Telescopes

K-Number: K223885 · 2023-09-14

ApplicantKarl Storz Endoscopy America, Inc.

Decision Date2023-09-14

Product CodeHIH

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

HOPKINS Telescopes 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 2023-09-14 under 510(k) number K223885. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOPKINS Telescopes?

HOPKINS Telescopes is a medical device that received FDA 510(k) clearance on 2023-09-14. The listed applicant is Karl Storz Endoscopy America, Inc.. The 510(k) number is K223885.

When did HOPKINS Telescopes receive FDA 510(k) clearance?

HOPKINS Telescopes received FDA 510(k) clearance on 2023-09-14, under 510(k) number K223885.

Who is the listed applicant for HOPKINS Telescopes?

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 HOPKINS Telescopes?

The FDA product code for HOPKINS Telescopes is HIH.

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Other records listing Karl Storz Endoscopy America, Inc. as applicant

K252624KARL STORZ Laryngoscopes and Accessories K240506KARL STORZ Holders 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-K223520UNIDRIVE SIII System K223923HOPKINS Telescopes K221893KARL STORZ Bipolar Resectoscopes with HF Cable

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Related Devices (Code: 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.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.