Scivita Medical Technology Co., Ltd. FDA Record
Scivita Medical Technology Co., Ltd. has 0 FDA recalls, 1 inspection, 13 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Scivita Medical Technology Co., Ltd." is on file.
- Latest inspection
- Apr 10, 2025 · NAI
- Latest 510(k)
- Aug 14, 2026
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 13 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 1 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 10, 2025 | Suzhou, China | Devices | No Action Indicated (NAI) | 3020746799 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3020746799 | Suzhou, China | 1 | Apr 10, 2025 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| 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… | Jan 20, 2026 |
| K243708 | Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B… | Mar 27, 2025 |
| K250210 | Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P… | 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 |
| K221252 | Scivita 4KINSIGHT ICG Imaging System | Jan 13, 2023 |
| K210379 | Broncho Videoscope System | Jul 28, 2021 |
| K203255 | 4K UHD Laparoscope | Feb 24, 2021 |
| K200216 | 4K UHD Camera System | Aug 21, 2020 |
| K183675 | 3D Visualization System | Sep 25, 2019 |
Scivita Medical Technology Co., Ltd. and the FDA: common questions
Has Scivita Medical Technology Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Scivita Medical Technology Co., Ltd." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Scivita Medical Technology Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Scivita Medical Technology Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Scivita Medical Technology Co., Ltd.?
The most recent FDA inspection on file ended Apr 10, 2025 at Suzhou, China and was classified NAI. FDA has 1 inspection of Scivita Medical Technology Co., Ltd. on file.
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