Atlas FDA

Lapro-Clip Auto Suture Reusable Long Clip Applier

FDA 510(k) clearance K143598 · decided 2015-03-12

Clearance details

K-number
K143598
Device name
Lapro-Clip Auto Suture Reusable Long Clip Applier
Applicant
Covidien, LLC
Decision
Substantially Equivalent
Date received
2014-12-18
Decision date
2015-03-12
Days to decision
84 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
North Haven, CT, 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
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S012)Covidien, LLC2005-06-24
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S011)Covidien, LLC2005-02-25
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S006)Covidien, LLC2003-01-07
OXI FIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S009)Covidien, LLC2002-11-25
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S008)Covidien, LLC2002-11-25
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S010)Covidien, LLC2002-11-15
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S005)Covidien, LLC2002-06-28
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S007)Covidien, LLC2002-04-18