Atlas FDA

U-CLIP DEVICE, MODELS B140, B160 AND B180

FDA 510(k) clearance K053252 · decided 2005-12-16

Clearance details

K-number
K053252
Device name
U-CLIP DEVICE, MODELS B140, B160 AND B180
Applicant
Medtronic Vascular
Decision
Substantially Equivalent
Date received
2005-11-21
Decision date
2005-12-16
Days to decision
25 days
Clearance type
Special
Product code
FZP
Device class
2
Regulation number
878.4300
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Shoreview, MN, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating Clips (K254231)Taiwan Surgical Corporation2026-07-20
InnoClip Disposable Clip Applier (K253903)Taiwan Surgical Corporation2025-12-22
InnoClip Clip Applier (K253781)Taiwan Surgical Corporation2025-12-22
Disposable Polymer Ligation Clips (K250643)Hangzhou Kangji Medical Instrument Co., Ltd.2025-11-20
Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips (K251054)Teleflex Medical2025-07-03
GEM ZIPCLIP (K242541)Synovis Micro Companies Alliance A Subsidiary of Baxter Int2025-01-15
SOLID CLIP™ Single Use Clip Applier (K221495)Medscope Biotech Co., Ltd.2024-07-18
Hem-o-lok® Ligating Clips (K232970)Teleflex Medical2024-01-12
angiOCCLUDE Ligating Clips (K230966)A2 Medical Systems, LLC2023-09-19
LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320) (K232313)Ethicon Endo Surgery, LLC2023-08-29
Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML) (K230480)Teleflex Medical2023-04-28
DuraFuse Clip and Applier System (K213813)Neuramedica, Inc.2022-07-22

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Resolute Onyx Zotarolimus-Eluting Coronary Stent System - RX and OTW; Onyx Frontier Zotarolimus-Eluting Coronary Stent S (P160043/S089)Medtronic Vascular2025-12-19
Endurant II/IIs Stent Graft System (P100021/S131)Medtronic Vascular2025-10-23
Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System (P100021/S129)Medtronic Vascular2025-09-15
Resolute Onyx (P160043/S088)Medtronic Vascular2025-06-26
Endurant Stent Graft System (P100021/S130)Medtronic Vascular2025-06-12
Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S073)Medtronic Vascular2025-06-12
Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S072)Medtronic Vascular2025-05-20
Valiant Thoracic Stent Graft with the Captiva Delivery System (P100040/S069)Medtronic Vascular2025-05-08