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510(k) K202124

Device
Aesculap PAS-Port Proximal Anastomosis System
Applicant
Aesculap Inc.
510(k) number
K202124
Product code
FZP  
Decision
Substantially Equivalent (SESE)
Decision date
2020-09-02
Date received
2020-07-31
Regulation
878.4300
Classification name
Clip, Implantable
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Sierra Mertz
Address
3773 Corporate Pkwy. Center Valley PA US 18034 18034

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FZP  #

510(k), Device, Applicant table
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
K202994InnoClip Disposable Clip Applier, InnoClip Clip ApplierTaiwan Surgical Corporation2022-01-04
K200166Mirus Ligating Clip, Mirus Ligating Clip ApplierM/s. Meril Endo Surgery Private Limited.2020-11-23
K192711Dannik Titanium Ligation ClipDannik2019-12-20

Legacy Summary#

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FDA Review#

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