3D Visualization System
FDA 510(k) K183675 · Scivita Medical Technology Co., Ltd.
510(k) numberK183675
Submission
- Device name
- 3D Visualization System
- Applicant
- Scivita Medical Technology Co., Ltd.
Suzhou, CN - Received
- December 28, 2018
- Decision date
- September 25, 2019
- 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).
Other 510(k)s with product code GCJ
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| K262397 | CuratOR EX2742GCJ · Traditional | Eizo Corporation | 09/11/2026SE |
| 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 |
More from TroCare, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K262552 | Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)FGB · Special | 08/14/2026SE |
| K251338 | Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G…FBN · Traditional | 01/20/2026SE |
| K243708 | Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P…FGB · Traditional | 03/27/2025SE |
| K250210 | Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B…EOQ · Special | 03/19/2025SE |
| K240289 | Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D)EOQ · Traditional | 10/23/2024SE |
| K240192 | Single-use Extraction BasketsLQR · Traditional | 10/15/2024SE |
| K231521 | Broncho Videoscope SystemEOQ · Traditional | 11/14/2023SE |
| K222812 | InsufflatorHIF · Traditional | 05/16/2023SE |
| K221252 | Scivita 4KINSIGHT ICG Imaging SystemGCJ · Traditional | 01/13/2023SE |
| K210379 | Broncho Videoscope SystemEOQ · Traditional | 07/28/2021SE |
Questions and answers
When was 3D Visualization System cleared by the FDA?
3D Visualization System (K183675) received a 510(k) decision of Substantially Equivalent on September 25, 2019, 271 days after the submission was received.
What is the product code of K183675?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.