Scivita Medical Technology Co., Ltd.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Scivita Medical Technology Co., Ltd.” (first 2019, latest 2026), across 7 product codes in 4 review panels. Median 510(k) review time under this name: 206 days. Since 2017 the median was 206 days, against 126 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2019 | 1 | 271 |
| 2020 | 1 | 206 |
| 2021 | 2 | 140 |
| 2022 | 0 | — |
| 2023 | 3 | 239 |
| 2024 | 2 | 265 |
| 2025 | 2 | 84 |
| 2026 | 2 | 143 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Scivita Medical Technology Co., Ltd. took a median 206 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 126 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | 4 | 4 |
| GCJ | Laparoscope, General & Plastic Surgery | 3 | 3 |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | 2 | 2 |
| FBN | Choledochoscope And Accessories, Flexible/Rigid | 1 | 1 |
| HET | Laparoscope, Gynecologic (And Accessories) | 1 | 1 |
| HIF | Insufflator, Laparoscopic | 1 | 1 |
| LQR | Dislodger, Stone, Biliary | 1 | 1 |
Review panels
- Ear, Nose and Throat (4)
- Gastroenterology and Urology (4)
- General and Plastic Surgery (3)
- Obstetrics and Gynecology (2)
Most recent Scivita Medical Technology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262552 | Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B) | FGB | 2026-08-14 | 21 |
| 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 | 2026-01-20 | 265 |
| 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 | 2025-03-27 | 115 |
| 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 | 2025-03-19 | 54 |
| K240289 | Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D) | EOQ | 2024-10-23 | 265 |
| K240192 | Single-use Extraction Baskets | LQR | 2024-10-15 | 265 |
| K231521 | Broncho Videoscope System | EOQ | 2023-11-14 | 172 |
| K222812 | Insufflator | HIF | 2023-05-16 | 239 |
| K221252 | Scivita 4KINSIGHT ICG Imaging System | GCJ | 2023-01-13 | 256 |
| K210379 | Broncho Videoscope System | EOQ | 2021-07-28 | 169 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Scivita Medical Technology Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Scivita Medical Technology Co., Ltd.?
FDA lists 13 510(k) clearances under the applicant name “Scivita Medical Technology Co., Ltd.” (first 2019, latest 2026), across 7 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Scivita Medical Technology Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Scivita Medical Technology Co., Ltd. is 206 days. Since 2017: 206 days, versus 126 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Scivita Medical Technology Co., Ltd.?
The most frequent FDA product codes under this applicant name are EOQ (Bronchoscope (Flexible Or Rigid), 4); GCJ (Laparoscope, General & Plastic Surgery, 3); FGB (Ureteroscope And Accessories, Flexible/Rigid, 2).
Next steps
- See all 13 Scivita Medical Technology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code EOQ, Scivita Medical Technology Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.