Taiwan Surgical Corporation
FDA Regulatory Profile
Taiwan Surgical Corporation has 0 FDA recalls, 1 inspection, 9 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Sep 4, 2025 · VAI
- Latest 510(k)
- Aug 25, 2026
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 0 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 9 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 1 | Nov 9, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Sep 4, 2025 | Zhubei, Taiwan | Devices | Voluntary Action Indicated (VAI) | 3010605922 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3010605922 | Zhubei, Taiwan | 1 | Sep 4, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K252535 | Inno-Switch Laparoscopic Instruments | Aug 25, 2026 |
| K254231 | Inno-Hook Disposable Clip Appliers (Ligating Clips) and Inno-Hook Ligating Clips | Jul 20, 2026 |
| K252532 | Inno-Port Disposable Bladed Trocar | Jun 2, 2026 |
| K253903 | InnoClip Disposable Clip Applier | Dec 22, 2025 |
| K253781 | InnoClip Clip Applier | Dec 22, 2025 |
| K223593 | Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar | Mar 22, 2023 |
| K202994 | InnoClip Disposable Clip Applier, InnoClip Clip Applier | Jan 4, 2022 |
| K150259 | CLIP PLUS Disposable Clip Applier,ML;CLIP PLUS Disposable Clip Applier,L | Nov 6, 2015 |
| K150253 | Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation, 450mm | Apr 1, 2015 |