1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM
FDA 510(k) K231854 · Stryker
510(k) numberK231854
Submission
- Device name
- 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM
- Applicant
- Stryker
San Jose, CA, US - Received
- June 23, 2023
- Decision date
- September 20, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OWN – Confocal Optical Imaging
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Collection of light signals for visualization of cellular microstructures.
Other 510(k)s with product code OWN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254180 | PerfusiX-ImagingOWN · Traditional | LIMIS Development B.V. | 07/24/2026SE |
| K242163 | SmartSurgN Visualization SystemOWN · Traditional | SmartsurgN, Inc. | 04/20/2026SE |
| K254242 | KARL STORZ ICG Imaging System with RUBINA® LensOWN · Traditional | Karl Storz SE & CO. KG | 02/26/2026SE |
| K251852 | cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)OWN · Traditional | VPIX Medical, Inc. | 02/13/2026SE |
| K260108 | L12 LED Light Source with AIMOWN · Special | Stryker Endoscopy | 02/12/2026SE |
| K253972 | IMAGE1 (TC400US); X-to-4U Adapter (TC040)OWN · Traditional | Karl Storz SE & CO. KG | 02/12/2026SE |
| K251336 | VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light…OWN · Traditional | Olympus Medical Systems Corp. | 11/12/2025SE |
| K243711 | Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System…OWN · Traditional | Wuxi Hisky Medical Technologies Co., Ltd. | 07/24/2025SE |
| K243591 | OPTOVISION Endoscopic Light Source UnitOWN · Traditional | Optosurgical, LLC | 02/19/2025SE |
| K241275 | Histolog® Scanner (Hardware 2.4, Software 3.3)OWN · Traditional | Samantree Medical SA | 08/19/2024SE |
More from Samantree Medical SA
| 510(k) | Device | Decision |
|---|---|---|
| K261481 | Pangea Femur Reconstruction SystemHSB · Traditional | 06/29/2026SE |
| K253640 | T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemHSB · Traditional | 02/03/2026SE |
| K253202 | Hoffmann LRF SystemKTT · Traditional | 12/19/2025SE |
| K251400 | T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemHSB · Traditional | 08/20/2025SE |
| K250163 | T2 Alpha Femur Retrograde Nailing SystemHSB · Traditional | 08/13/2025SE |
| K242445 | Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…HRS · Traditional | 10/06/2024SE |
| K233919 | VariAx 2 Distal Radius SystemHRS · Traditional | 03/25/2024SE |
| K233741 | Hoffmann LRF SystemKTT · Special | 12/21/2023SE |
| K230045 | HipCheckQIH · Traditional | 09/29/2023SE |
| K232157 | Connected OR Hub with Device and Voice Control, SDC4K Information Management System with…GCJ · Special | 08/18/2023SE |
Questions and answers
When was 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM cleared by the FDA?
1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM (K231854) received a 510(k) decision of Substantially Equivalent on September 20, 2023, 89 days after the submission was received.
What is the product code of K231854?
The FDA product code is OWN – Confocal Optical Imaging, a Class II (moderate risk) device regulated under 21 CFR 876.1500.