Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D)
FDA 510(k) K240289 · Scivita Medical Technology Co., Ltd.
Submission
- Device name
- Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D)
- Applicant
- Scivita Medical Technology Co., Ltd.
Suzhou, CN - Received
- February 1, 2024
- Decision date
- October 23, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EOQ – Bronchoscope (Flexible Or Rigid)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4680
- Specialty
- Ear, Nose, Throat
A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. If the device is reprocessed, reprocessing validation data for this device type must be included in a 510(k) submission. If the device is reusable, validated…
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| K262552 | Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)FGB · Special | 08/14/2026SE |
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| 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 |
| 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 |
| K203255 | 4K UHD LaparoscopeGCJ · Traditional | 02/24/2021SE |
Questions and answers
When was Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D) cleared by the FDA?
Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D) (K240289) received a 510(k) decision of Substantially Equivalent on October 23, 2024, 265 days after the submission was received.
What is the product code of K240289?
The FDA product code is EOQ – Bronchoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4680.