FDA Registration
Active
🇹🇼 Taiwan
TAIWAN SURGICAL CORPORATION
Reg #: 3010605922
·
FEI: 3010605922
·
Expires 2026
Products
6
Proprietary Names
16
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- TAIWAN SURGICAL CORPORATION
- Registration Number
- 3010605922
- FEI Number
- 3010605922
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3F., No.12, Sec.2, ShengYi Rd., Zhubei City, Hsinchu County
- City
- Zhubei City Hsinchu
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K202994
Owner / Operator
- Firm Name
- Taiwan Surgical Corporation
- Operator Number
- 10045427
- Address
- 3F., No. 12, Sec. 2, Shengyi Rd.,
- City
- Zhubei City
- State
- Hsinchu
- Postal Code
- 302
- Country
- TW
- Correspondent
- Ken Chen
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Clip, Implantable | FZP | Class 2 | General, Plastic Surgery | No | 2022-10-24 |
| Applier, Surgical, Clip | GDO | Class 1 | General, Plastic Surgery | No | 2022-10-24 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2014-02-21 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2015-05-04 |
| Stapler, Skin | QQS | Class 1 | General Hospital | No | 2023-03-07 |
| Staple, Removable (Skin) | GDT | Class 1 | General, Plastic Surgery | No | 2013-11-14 |
Proprietary Names
InnoClip Disposable Clip Applier
InnoClip Clip Applier
InnoClip EndoGuidance Titanium Ligating Clip
CLIP PLUS Disposable Clip Applier
"Taiwan Surgical" SURGICAL TRAY
Taiwan Surgical Disposable Suction Irrigation
MDTSI-33 5mm x 33mm Stainless Steel Probe, 290cm Soft Tube EndoGuidance Suction Irrigation System
MDTSI-45 5mm x 45mm Stainless Steel Probe, 290cm Soft Tube EndoGuidance Suction Irrigation System
Taiwan Surgical Inno-Port Disposable Trocar Access
Taiwan Surgical Disposable Trocar
SkinPlus Disposable Skin Stapler
InnoClip Reusable Clip Applier Handle
Inno-Hook Reusable Clip Applier
Taiwan Surgical Inno-Port Disposable Bladed Trocar Access
SKIN PLUS TM Disposable Skin Staple Remover
"Taiwan Surgical" Disposable Skin Staple Remover
Establishment Types
Manufacture Medical Device