# Scivita Medical Technology Co., Ltd.

- Location (FDA's records): Suzhou, CN
- FDA decisions: 13 (2019–2026): 13 510(k) clearances
- Product codes: EOQ (4), GCJ (3), FGB (2), FBN (1), LQR (1), HET (1), HIF (1)
- 510(k) review time since 2016: median 172 days, against 134 for FDA's reviews in the same codes and years (4 of 11 faster)
- Predicates its devices cite: 14 (5 its own); citations of its devices by later devices: 7 (5 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Boston Scientific Corp: 2 (https://510kreport.com/company/boston-scientific)
- Olympus Medical Systems Corp.: 2 (https://510kreport.com/company/olympus-medical-systems)
- Zhuhai Pusen Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/zhuhai-pusen-medical-technology)
- Novadaq Technologies Ulc. (Now A Part of Stryker): 1 (https://510kreport.com/company/novadaq-technologies-ulc-now-a-part-of-stryker)
- Olympus Winter & Ibe GmbH: 1 (https://510kreport.com/company/olympus-winter-ibe)
- W.O.M. World of Medicine GmbH: 1 (https://510kreport.com/company/wom-world-of-medicine)
- Hunan Vathin Medical Instrument Co., Ltd.: 1 (https://510kreport.com/company/hunan-vathin-medical-instrument)

## Firms that cite its devices most
- Guangdong Optomedic Technologies, Inc.: 1 (https://510kreport.com/company/guangdong-optomedic-technologies)
- Weyo Surgical Technology, Ltd.: 1 (https://510kreport.com/company/weyo-surgical-technology)

## Its most-cited devices
- K210379: Broncho Videoscope System (2021), cited by 3
- K222812: Insufflator (2023), cited by 2
- K243708: Urology Videoscope System  (Single-use Flexible Ureteroscope:  SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.) (2025), cited by 1
- K231521: Broncho Videoscope System (2023), cited by 1

## Recent decisions
- K262552: Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B) (Aug 14, 2026)
- K251338: Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D) (Jan 20, 2026)
- K243708: Urology Videoscope System  (Single-use Flexible Ureteroscope:  SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.) (Mar 27, 2025)
- K250210: Broncho Videoscope System  (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D)) (Mar 19, 2025)
- K240289: Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D) (Oct 23, 2024)
- K240192: Single-use Extraction Baskets (Oct 15, 2024)
- K231521: Broncho Videoscope System (Nov 14, 2023)
- K222812: Insufflator (May 16, 2023)

Source page: https://510kreport.com/company/scivita-medical-technology