Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source
FDA 510(k) K221591 · Schoelly Fiberoptic GmbH
510(k) numberK221591
Submission
- Device name
- Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source
- Applicant
- Schoelly Fiberoptic GmbH
Denzlingen, DE - Received
- June 2, 2022
- Decision date
- February 23, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GCJ – Laparoscope, General & Plastic Surgery
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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| K260884 | UNIDRIVE Select SystemGCJ · Traditional | Karl Storz SE & CO. KG | 09/01/2026SE |
| K260972 | OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorGCJ · Traditional | Sony Corporation | 08/26/2026SE |
| K261139 | VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)GCJ · Traditional | Freyja Healthcare, LLC | 08/13/2026SE |
| K253541 | EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ…GCJ · Traditional | Medical Impact | 07/24/2026SE |
| K261614 | LED LCD Monitor (OEV-271H)GCJ · Traditional | Lg Electronics.Inc | 07/17/2026SE |
| K261249 | Universal Seal (5-12 mm)GCJ · Traditional | Intuitive Surgical, Inc. | 07/14/2026SE |
| K260710 | FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm…GCJ · Traditional | FloShield, Inc. | 06/11/2026SE |
| K260414 | Tech-Image Video Endoscope SystemGCJ · Traditional | Tech-Image CO., LTD. | 06/10/2026SE |
| K253994 | TroKit Laparoscope Lens WiperGCJ · Traditional | TroCare, LLC | 06/04/2026SE |
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| K233225 | SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head…GCJ · Traditional | 06/20/2024SE |
| K201617 | TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control…HET · Traditional | 03/12/2021SE |
| K201970 | Schoelly Cystoscopes/Hysteroscopes and AccessoriesHIH · Traditional | 10/08/2020SE |
| K151308 | Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope SetFGA · Traditional | 02/09/2016SE |
| K150158 | Schoelly Cystoscopes/Hysteroscopes and AccessoriesHIH · Traditional | 03/09/2015SE |
| K143673 | CMOS Video Nasopharyngoscope SystemEOB · Special | 03/04/2015SE |
| K142249 | Schoelly SinuscopeEOB · Traditional | 01/27/2015SE |
| K143221 | Schoelly LaparoscopeGCJ · Special | 12/05/2014SE |
| K132009 | Cmos Video Nasopharyngoscope SystemEOB · Traditional | 04/09/2014SE |
| K992362 | Flexiscope Iq 101FET · Traditional | 08/05/1999SE |
Questions and answers
When was Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source cleared by the FDA?
Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source (K221591) received a 510(k) decision of Substantially Equivalent on February 23, 2023, 266 days after the submission was received.
What is the product code of K221591?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.