FDA.report

510(k) K202994

Device
InnoClip Disposable Clip Applier, InnoClip Clip Applier
Applicant
Taiwan Surgical Corporation
510(k) number
K202994
Product code
FZP
Decision
Substantially Equivalent (SESE)
Decision date
2022-01-04
Date received
2020-10-01
Regulation
878.4300
Classification name
Clip, Implantable
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Ken Chen
Address
3f., # 12, Sec. 2 Sheng Yi Rd. Zhubei City TW 30261 30261

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
14717480902375InnoClipTAIWAN SURGICAL CORPORATION2023-07-11
14717480902368InnoClipTAIWAN SURGICAL CORPORATION2023-07-11
14717480902306InnoClipTAIWAN SURGICAL CORPORATION2023-07-11
04717480902354InnoClipTAIWAN SURGICAL CORPORATION2023-07-11
04717480902347InnoClipTAIWAN SURGICAL CORPORATION2023-07-11

Other 510(k) Records For Product Code FZP

510(k)DeviceApplicantDecision date
K253903InnoClip Disposable Clip ApplierTaiwan Surgical Corporation2025-12-22
K253781InnoClip Clip ApplierTaiwan Surgical Corporation2025-12-22
K250643Disposable Polymer Ligation ClipsHangzhou Kangji Medical Instrument Co., Ltd.2025-11-20
K251054Hem-o-lok™ PurplePlus™ Large Polymer Ligating ClipsTeleflex Medical2025-07-03
K242541GEM ZIPCLIPSynovis Micro Companies Alliance A Subsidiary of Baxter Int2025-01-15
K221495SOLID CLIP™ Single Use Clip ApplierMedscope Biotech Co., Ltd.2024-07-18
K232970Hem-o-lok® Ligating ClipsTeleflex Medical2024-01-12
K230966angiOCCLUDE Ligating ClipsA2 Medical Systems, LLC2023-09-19
K232313LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320)Ethicon Endo Surgery, LLC2023-08-29
K230480Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)Teleflex Medical2023-04-28
K213813DuraFuse Clip and Applier SystemNeuramedica, Inc.2022-07-22
K220006angioLOCK Polymer Ligating ClipA2 Medical Systems, LLC2022-03-02
K200166Mirus Ligating Clip, Mirus Ligating Clip ApplierM/s. Meril Endo Surgery Private Limited.2020-11-23
K202124Aesculap PAS-Port Proximal Anastomosis SystemAesculap, Inc.2020-09-02
K192711Dannik Titanium Ligation ClipDannik2019-12-20