Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010605922

FEI Number

3010605922

Entity Name

TAIWAN SURGICAL CORPORATION

City/State/Country

Zhubei City Hsinchu, TW

Establishment Address

3F., No.12, Sec.2, ShengYi Rd., Zhubei City, Hsinchu County, Zhubei City Hsinchu 302, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Taiwan Surgical Corporation (Owner Number: 10045427)

Owner / Operator Contact Address

3F., No. 12, Sec. 2, Shengyi Rd.,, Zhubei City, TW-HSQ 302, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 InnoClip Clip Applier InnoClip Disposable Clip Applier 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2022-10-24
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2022-10-24
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2014-02-21
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2015-05-04
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2026-03-13
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2026-03-13
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2026-03-13
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2026-03-13
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2023-03-29
QQS	Stapler, Skin	General Hospital	Class 1	878.4740	2023-03-07
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2025-11-26

Official Correspondent

Ken Chen

US Agent Details

Matt Dryden Email: matt.dryden@promedic.cc Phone: (239) 3076063

Related Public Records

Same Entity

Taiwan Surgical Corporation

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07
K153773	Olympus Medical Systems Corp.	Disposal Lens Cleaning Sheath	2016-11-22
K940141	Micro-Medical Devices, Inc.	LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH	1994-05-19
K933812	Advanced Surgical, Inc.	ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES	1993-12-13
K254228	Karl Storz SE & CO. KG	KARL STORZ Trocars with Valve Seals	2026-05-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010605922. Last updated year: 2026. Please use registration number 3010605922 when referencing this establishment in official correspondence.