OWN · Confocal Optical Imaging
Gastroenterology, Urology · 21 CFR 876.1500 · Class 2
Overview
| Product Code | OWN |
|---|---|
| Device Name | Confocal Optical Imaging |
| Regulation | 21 CFR 876.1500 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
Identification
An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
Classification Rationale
(1) Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. (2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
Special Controls
*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
Recent Cleared Devices (20 of 60)
Showing 20 most recent of 60 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K254242 | KARL STORZ ICG Imaging System with RUBINA® Lens | Karl Storz SE & CO. KG | Feb 26, 2026 | SESE |
| K251852 | cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200) | VPIX Medical, Inc. | Feb 13, 2026 | SESE |
| K260108 | L12 LED Light Source with AIM | Stryker Endoscopy | Feb 12, 2026 | SESE |
| K253972 | IMAGE1 (TC400US); X-to-4U Adapter (TC040) | Karl Storz SE & CO. KG | Feb 12, 2026 | SESE |
| K251336 | VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA) | Olympus Medical Systems Corp. | Nov 12, 2025 | SESE |
| K243711 | Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Imaging System (BrightP880); Confocal Microprobe Imaging System (BrightP860); Confocal Microprobe Imaging System (BrightP780); Confocal Microprobe Imaging System (BrightP750); Confocal Microprobe Imaging System (BrightP680); Confocal Microprobe Imaging System (BrightP660); Confocal Microprobe Imaging System (BrightP600); Confocal Microprobe Imaging System (BrightP580); | Wuxi Hisky Medical Technologies Co., Ltd. | Jul 24, 2025 | SESE |
| K243591 | OPTOVISION Endoscopic Light Source Unit | Optosurgical, LLC | Feb 19, 2025 | SESE |
| K241275 | Histolog® Scanner (Hardware 2.4, Software 3.3) | Samantree Medical SA | Aug 19, 2024 | SESE |
| K233333 | KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit | Karl Storz SE & CO. KG | Nov 21, 2023 | SESE |
| K232857 | KARL STORZ ICG Imaging System | Karl Storz SE & CO. KG | Nov 6, 2023 | SESE |
| K231854 | 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM | Stryker | Sep 20, 2023 | SESE |
| K231344 | ActivSight Intraoperative Imaging System | Activ Surgical, Inc. | Aug 2, 2023 | SESE |
| K230407 | FloNavi Open Field Fluorescence Imaging System | Guangdong Optomedic Technologies, Inc. | Jul 17, 2023 | SESE |
| K230754 | L12 LED Light Source with AIM | Stryker | Apr 11, 2023 | SESE |
| K213943 | SmartSurgN Visualization System | Smartsurgn Incorporated | Nov 29, 2022 | SESE |
| K223020 | VS3-Iridium System (VS3-IR) | Visionsense, Ltd. | Oct 28, 2022 | SESE |
| K221611 | 780 nm L11 LED Light Source with AIM | Stryker | Jun 29, 2022 | SESE |
| K220477 | Cellvizio 100 series system with confocal Miniprobes | Mauna Kea Technologies | Apr 11, 2022 | SESE |
| K210265 | VS3 Iridium Sytem | Visionsense, Ltd. | Nov 22, 2021 | SESE |
| K212695 | KARL STORZ ICG Imaging System | Karl Storz Endoscopy America | Nov 15, 2021 | SESE |
Top Applicants
- Mauna Kea Technologies — 15 clearances
- Stryker — 6 clearances
- Karl Storz SE & CO. KG — 4 clearances
- Novadaq Technologies Ulc. (Now A Part of Stryker) — 4 clearances
- Visionsense, Ltd. — 4 clearances
