Atlas FDA

WECK HEM-O-LOK AUTOMATIC LIGATING CLIP APPLIER

FDA 510(k) clearance K021808 · decided 2002-08-14

Clearance details

K-number
K021808
Device name
WECK HEM-O-LOK AUTOMATIC LIGATING CLIP APPLIER
Applicant
Weck
Decision
Substantially Equivalent
Date received
2002-06-03
Decision date
2002-08-14
Days to decision
72 days
Clearance type
Traditional
Product code
FZP
Device class
2
Regulation number
878.4300
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Durham, NC, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Weck

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

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

RecordFirmDate
Weck Hemoclip Traditional Ligating Clips, Rx Only, Sterile, Teleflex Medical, RTP, NC 2770 recall (Z-0156-2009)Telefelx Medical2008-09-16
Weck Hemoclip Plus Ligating Clips, Rx Only, Sterile, Teleflex Medical, RTP, NC 27709 USA. recall (Z-0157-2009)Telefelx Medical2008-09-16
Weck , Horizon Titanium Clips, Rx Only, Sterile, Teleflex Medical, RTP, NC 27709, USA. The recall (Z-0158-2009)Telefelx Medical2008-09-16
WECK Hem-o-lok Non-absorbable Polymer Ligation Clips, Rx Only, Sterile, Teleflex Medical, recall (Z-0159-2009)Telefelx Medical2008-09-16
WECK HemoClip Auto, Rx Only, Sterile, Teleflex Medical, RTC, NC 27709. The use of the reus recall (Z-0160-2009)Telefelx Medical2008-09-16
Weck Hem-o-lok Endo 5 Automatic Clip Applier with Medium Polymer Ligating Clips; Rx, steri recall (Z-1099-06)Teleflex Medical2006-06-09