Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Schoelly Cystoscopes/Hysteroscopes and Accessories

K-Number: K201970 · 2020-10-08

ApplicantSchoelly Fiberoptic GmbH
Decision Date2020-10-08
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Schoelly Cystoscopes/Hysteroscopes and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Schoelly Fiberoptic GmbH. It received FDA 510(k) clearance on 2020-10-08 under 510(k) number K201970. 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 Schoelly Cystoscopes/Hysteroscopes and Accessories?

Schoelly Cystoscopes/Hysteroscopes and Accessories is a medical device that received FDA 510(k) clearance on 2020-10-08. The listed applicant is Schoelly Fiberoptic GmbH. The 510(k) number is K201970.

When did Schoelly Cystoscopes/Hysteroscopes and Accessories receive FDA 510(k) clearance?

Schoelly Cystoscopes/Hysteroscopes and Accessories received FDA 510(k) clearance on 2020-10-08, under 510(k) number K201970.

Who is the listed applicant for Schoelly Cystoscopes/Hysteroscopes and Accessories?

The FDA 510(k) record lists Schoelly Fiberoptic GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Schoelly Cystoscopes/Hysteroscopes and Accessories?

The FDA product code for Schoelly Cystoscopes/Hysteroscopes and Accessories is HIH.

Other records listing Schoelly Fiberoptic GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233225SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)K221591Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light SourceK201617TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU))K151308Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set

Related Devices (Code: HIH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253020Strauss Surgical Resection InstrumentsAmerican Medical Endoscopy, Inc.K254050Manual Tissue Removal DeviceSuzhou AcuVu Medical Technology Co., Ltd.K254251InnovexView (GC146-17, GC150-20, GC155-23)Shanghai AnQing Medical Instrument Co., Ltd.K252793ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C)Jiangsu Jiyuan Medical Technology Co., Ltd.K252012SPY Cystoscope/HysteroscopeStryker EndoscopyK243382RZ Resectoscope SystemRz Medizintechnik GmbH

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.

↑