Data / Medical devices / Taiwan / Taiwan Surgical Corporation
Taiwan Surgical Corporation: FDA-registered device maker in Zhubei City Hsinchu(County), Taiwan, 8 510(k) clearances
Taiwan Surgical Corporation is registered with the FDA (registration 3010605922) in Zhubei City Hsinchu(County), Taiwan. It lists 6 device types. The FDA files 8 510(k) clearances under its listings, the newest dated July 20, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3010605922
- Address
- 3F., No.12, Sec.2, ShengYi Rd. Zhubei City, Hsinchu County, Zhubei City Hsinchu(County), Taiwan, 302
- Owner or operator
- Taiwan Surgical Corporation (10045427)
- Roles
- Manufacturer
- First device listed
- November 14, 2013
- Registered through
- 2027
- Brand names listed
- "Taiwan Surgical" Disposable Skin Staple Remover, "Taiwan Surgical" SURGICAL TRAY, CLIP PLUS Disposable Clip Applier, Inno-Hook Disposable Clip Applier(Ligating Clips), Inno-Hook Reusable Clip Applier, InnoClip Clip Applier, InnoClip Disposable Clip Applier, InnoClip EndoGuidance Titanium Ligating Clip and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applier, Surgical, Clip | GDO | 1 | Manufacturer | accessdata.fda.gov |
| Clip, Implantable | FZP | 2 | Manufacturer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Manufacturer | accessdata.fda.gov |
| Staple, Removable (Skin) | GDT | 1 | Manufacturer | accessdata.fda.gov |
| Stapler, Skin | QQS | 1 | Manufacturer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 20, 2026 | K254231 | Inno-Hook Disposable Clip Appliers (Ligating Clips) and Inno-Hook Ligating Clips | FZP | Substantially Equivalent | Taiwan Surgical Corporation | accessdata.fda.gov |
| June 2, 2026 | K252532 | Inno-Port Disposable Bladed Trocar | GCJ | Substantially Equivalent | Taiwan Surgical Corporation | accessdata.fda.gov |
| December 22, 2025 | K253903 | InnoClip Disposable Clip Applier | FZP | Substantially Equivalent | Taiwan Surgical Corporation | accessdata.fda.gov |
| December 22, 2025 | K253781 | InnoClip Clip Applier | FZP | Substantially Equivalent | Taiwan Surgical Corporation | accessdata.fda.gov |
| March 22, 2023 | K223593 | Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar | GCJ | Substantially Equivalent | Taiwan Surgical Corporation | accessdata.fda.gov |
| January 4, 2022 | K202994 | InnoClip Disposable Clip Applier, InnoClip Clip Applier | FZP | Substantially Equivalent | Taiwan Surgical Corporation | accessdata.fda.gov |
| November 6, 2015 | K150259 | CLIP PLUS Disposable Clip Applier,ML;CLIP PLUS Disposable Clip Applier,L | FZP | Substantially Equivalent | Taiwan Surgical Corporation | accessdata.fda.gov |
| April 1, 2015 | K150253 | Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation, 450mm | GCJ | Substantially Equivalent | Taiwan Surgical Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of Laparoscope, General & Plastic Surgery
- All makers of Applier, Surgical, Clip
- All makers of Clip, Implantable
- All makers of Tray, Surgical, Instrument
- All makers of Stapler, Skin
- All makers of Staple, Removable (Skin)
Updated July 20, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.