Scivita Medical Technology Co., Ltd.
suzhou Jiangsu, CN
SCIVITA MEDICAL TECHNOLOGY CO., LTD. appears in FDA device records in suzhou Jiangsu, CN. FDA records list 13 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 13 510(k) clearances for Scivita Medical Technology Co., Ltd. between 2019 and 2026. The busiest year on record is 2023, with 3. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 2 |
| 2023 | 3 |
| 2024 | 2 |
| 2025 | 2 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K262552 | Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B) | FGB | Substantially Equivalent | |
| 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) | FBN | Substantially Equivalent | |
| 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.) | FGB | Substantially Equivalent | |
| 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)) | EOQ | Substantially Equivalent | |
| K240289 | Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D) | EOQ | Substantially Equivalent | |
| K240192 | Single-use Extraction Baskets | LQR | Substantially Equivalent | |
| K231521 | Broncho Videoscope System | EOQ | Substantially Equivalent | |
| K222812 | Insufflator | HIF | Substantially Equivalent | |
| K221252 | Scivita 4KINSIGHT ICG Imaging System | GCJ | Substantially Equivalent | |
| K210379 | Broncho Videoscope System | EOQ | Substantially Equivalent | |
| K203255 | 4K UHD Laparoscope | GCJ | Substantially Equivalent | |
| K200216 | 4K UHD Camera System | HET | Substantially Equivalent | |
| K183675 | 3D Visualization System | GCJ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3020746799 | 3020746799 | SCIVITA MEDICAL TECHNOLOGY CO., LTD. | No.2, Qingqiu Street, Suzhou Industrial Park, 215000 Suzhou, Jiangsu Prov., P.R.CHINA, suzhou Jiangsu 215000 CN | 2026 | and 9 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HRXArthroscope
- EOQBronchoscope (Flexible Or Rigid)
- FBNCholedochoscope And Accessories, Flexible/Rigid
- FMHContainer, Specimen, Sterile
- FAJCystoscope And Accessories, Flexible/Rigid
- FFLDislodger, Stone, Basket, Ureteral, Metal
- LQRDislodger, Stone, Biliary
- NWBEndoscope, Accessories, Narrow Band Spectrum
- OCYEndoscopic Guidewire, Gastroenterology-Urology
- FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology
- HFBForceps, Biopsy, Gynecological
- FCLForceps, Biopsy, Non-Electric
- HIFInsufflator, Laparoscopic
- NMHLaparoscope And Accessories, Gynecologic, Reprocessed
- GCJLaparoscope, General & Plastic Surgery
- HETLaparoscope, Gynecologic (And Accessories)
- NTNLed Light Source
- EOBNasopharyngoscope (Flexible Or Rigid)
- IZISystem, X-Ray, Angiographic
- FGBUreteroscope And Accessories, Flexible/Rigid
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain