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FDA 510(k)

FLEXISCOPE IQ 101

K-Number: K992362 · 1999-08-05

ApplicantSchoelly Fiberoptic GmbH
Decision Date1999-08-05
Product CodeFET
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FLEXISCOPE IQ 101 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 1999-08-05 under 510(k) number K992362. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEXISCOPE IQ 101?

FLEXISCOPE IQ 101 is a medical device that received FDA 510(k) clearance on 1999-08-05. The listed applicant is Schoelly Fiberoptic GmbH. The 510(k) number is K992362.

When did FLEXISCOPE IQ 101 receive FDA 510(k) clearance?

FLEXISCOPE IQ 101 received FDA 510(k) clearance on 1999-08-05, under 510(k) number K992362.

Who is the listed applicant for FLEXISCOPE IQ 101?

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 FLEXISCOPE IQ 101?

The FDA product code for FLEXISCOPE IQ 101 is FET.

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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))K201970Schoelly Cystoscopes/Hysteroscopes and AccessoriesK151308Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope SetK984641FLEXISCOPE OPTOMODUL

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Related Devices (Code: FET)

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.

K2620794K Camera Head OLYMPUS CH-S700-08-LBOlympus Medical Systems Corp.K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01Fujifilm CorporationK261260HD Camera Head OLYMPUS CH-S200-08-LBOlympus Medical Systems CorporationK251734ProVee Video Processing Unit (PV-003)Proverum LimitedK250462UL UHD-Clear View 4K Camera System (UL-3Chip 4K)Univlabs Technologies Private LimitedK250204Endoscopic Camera SystemShenzhen Sophway 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.

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