Taiwan Surgical Corporation
Zhubei City Hsinchu, TW
TAIWAN SURGICAL CORPORATION appears in FDA device records in Zhubei City Hsinchu, TW. FDA records list 8 510(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 8 510(k) clearances for Taiwan Surgical Corporation between 2015 and 2026. The busiest year on record is 2015, with 2. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2015 | 2 |
| 2022 | 1 |
| 2023 | 1 |
| 2025 | 2 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K254231 | Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating Clips | FZP | Substantially Equivalent | |
| K252532 | Inno-Port Disposable Bladed Trocar | GCJ | Substantially Equivalent | |
| K253903 | InnoClip Disposable Clip Applier | FZP | Substantially Equivalent | |
| K253781 | InnoClip Clip Applier | FZP | Substantially Equivalent | |
| K223593 | Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar | GCJ | Substantially Equivalent | |
| K202994 | InnoClip Disposable Clip Applier, InnoClip Clip Applier | FZP | Substantially Equivalent | |
| K150259 | CLIP PLUS Disposable Clip Applier,ML;CLIP PLUS Disposable Clip Applier,L | FZP | Substantially Equivalent | |
| K150253 | Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation, 450mm | GCJ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010605922 | 3010605922 | TAIWAN SURGICAL CORPORATION | 3F., No.12, Sec.2, ShengYi Rd., Zhubei City Hsinchu(County) 302 TW | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
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