Weck

HEM-O-LOK Medium Large, Large Endoscopic Remover 5 Milimeter, 45 Centimeter

Registry build 21.09.26
9manufacturers in China registered for this device type
996catalogue numbers in this listing
3recalls on this code

Who Else Makes It

Concentrated in Jiangsu (3), Zhejiang (2), Shandong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GDO
Manufacturer City Province Registered as Device types
Sunny Medical Device (Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 11
Jiangsu Bana Medical Technology Co., Ltd. Changzhou Jiangsu Contract manufacturer 4
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Bothwin (Beijing) Medical Technology Co., Ltd. Beijng Beijing Manufacturer 25
Tonglu Wanhe Medical Instrument Co., Ltd. Hangzhou Zhejiang Manufacturer 24
Hangzhou Tonglu Shikonghou Medical Instrument Co., Ltd. Hangzhou Zhejiang Contract manufacturer 17
Tianjin Huahong Technology Co., Ltd. Tianjin Tianjin Contract manufacturer 6
Sinolinks Medical Innovation, Inc. Changzhou Jiangsu Complaint-file establishment 5
Fengh Medical Co., Ltd. Jiangyin Jiangsu Manufacturer 4

Record

Regulatory record for Weck
Listed by Teleflex Medical LLC, United States
FDA product code GDO
Device type Applier, Surgical, Clip
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Specification developer, Complaint-file establishment, Manufacturer
510(k) K021808
Record published 2023-11-21
Record revised 2026-02-09 (version 8)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date, serial number
Packaging Case of 6, box, box of 3
Sizes Length 5.597 to 23.34 in; width 1.4 to 7 in; length 29.5 to 48.5 cm; height 5.1 to 5.2 in; width 10.4 cm; depth 1.81 in; angle 5 °

Catalogue Numbers

Catalogue numbers for Weck
Catalogue number Size Status
IPN921532 Length 10.5 in In distribution
IPN927319 Length 7.785 in In distribution
IPN915188 Width 1.4 in In distribution
IPN009022 Length 10.48 in In distribution
IPN009019 Length 10.6 in In distribution
IPN927313 Length 7.881 in In distribution
IPN008910 Length 10.9 in In distribution
IPN004614 Width 5.12 in In distribution
IPN915114 Length 11.1 in In distribution
IPN009056 Length 45 cm In distribution
IPN914996 Length 11 in In distribution
IPN028301 Length 17.5 in In distribution
IPN008884 Length 10.75 in In distribution
IPN028204 Width 5.765 in In distribution
IPN914946 Length 11 in In distribution
IPN028226 Width 4.624 in In distribution
IPN028194 Width 5.12 in In distribution
IPN927309 Length 5.597 in In distribution
IPN931103 Length 14 in In distribution
IPN008936 Length 5.8 in In distribution
IPN927315 Length 7.765 in In distribution
IPN008915 Length 7.875 in In distribution
IPN008923 Length 10.828 in In distribution
IPN915191 In distribution
IPN931054 Length 14 in In distribution
IPN915002 Length 14 in In distribution
IPN028385 In distribution
IPN004617 Width 5.12 in In distribution
IPN028207 Width 4.65 in In distribution
IPN028256 Length 10.75 in In distribution
IPN008505 Length 8 in In distribution
IPN912414 Width 4.418 in In distribution
IPN927249 Length 10 in In distribution
IPN921645 Width 5.765 in In distribution
IPN931099 Width 4.27 in In distribution
IPN004993 Length 8 in In distribution
IPN915082 Length 10.7 in In distribution
IPN028178 Length 6 in In distribution
IPN028199 Width 4.335 in In distribution
IPN931031 Length 6 in In distribution
IPN028278 Length 10.4 in In distribution
IPN921684 Length 10.75 in In distribution
IPN915098 Length 7.765 in In distribution
IPN009054 Length 32 cm In distribution
IPN009057 In distribution
IPN028181 Width 3.85 in In distribution
IPN915199 In distribution
IPN927281 Width 5.795 in In distribution
IPN009029 Length 10.9 in In distribution
IPN028176 Length 23.34 in In distribution
IPN927271 Width 4.335 in In distribution
IPN008872 Length 7.8 in In distribution
IPN914941 Length 8 in In distribution
IPN931033 Width 3.485 in In distribution
IPN931108 Length 11 in In distribution
IPN028213 Width 5.795 in In distribution
IPN915198 Length 45 cm In distribution
IPN921647 Length 21.7 in In distribution
IPN028367 Length 45 cm In distribution
IPN008521 Width 4.984 in In distribution
IPN931101 Length 11 in In distribution
IPN914949 Width 4.668 in In distribution
IPN006976 Width 5.795 in In distribution
IPN028188 Length 8 in In distribution
IPN008992 Length 8 in In distribution
IPN005021 Width 5.765 in In distribution
IPN008877 Length 10.7 in In distribution
IPN921661 Width 4.984 in In distribution
IPN931076 Width 5.795 in In distribution
IPN008916 Length 11.1 in In distribution
IPN028325 Width 3.954 in In distribution
IPN028246 Length 10.75 in In distribution
IPN028216 Length 8 in In distribution
IPN008880 Length 5.597 in In distribution
IPN915038 Length 8 in In distribution
IPN915013 Width 3.694 in In distribution
IPN009063 In distribution
IPN003132 Length 6 in In distribution
IPN028257 Length 10.828 in In distribution
ME05RVLG In distribution
IPN931045 Width 3.64 in In distribution
IPN927301 Length 11 in In distribution
IPN008557 Width 4.418 in In distribution
IPN028232 Length 8 in In distribution
IPN915018 Length 6.25 in In distribution
IPN915085 Length 5.957 in In distribution
IPN915084 Length 10.7 in In distribution
IPN008567 Width 4.581 in In distribution
IPN914977 Length 11 in In distribution
IPN931109 Length 11 in In distribution
IPN039605 Length 8 in In distribution
IPN008606 Length 6 in In distribution
IPN915140 Length 6 in In distribution
IPN927294 Width 4.642 in In distribution
IPN921659 Length 6 in In distribution
IPN931060 Width 4.335 in In distribution
IPN915049 Length 11 in In distribution
IPN922086 Width 3.485 in In distribution
IPN004625 Width 5.12 in In distribution
IPN003128 Length 6 in In distribution
IPN028391 In distribution
IPN931079 Width 5.795 in In distribution
IPN028299 Length 14 in In distribution
IPN921653 Width 5.795 in In distribution
IPN921626 Length 11 in In distribution
ME05LGL In distribution
IPN927240 Length 10.9 in In distribution
ME05RVLGT In distribution
IPN915194 Length 45 cm In distribution
IPN028255 Length 11.1 in In distribution
IPN028304 Length 11 in In distribution
ME05RVLG In distribution
IPN039600 Length 11 in In distribution
IPN028206 Width 4.05 in In distribution
IPN921618 Length 6 in In distribution
IPN916586 Length 11 in In distribution
IPN028287 Width 3.85 in In distribution
ME05LG In distribution
IPN028264 Length 10.9 in In distribution
IPN915095 Length 10.75 in In distribution
IPN921656 Length 18.3 in In distribution
IPN931057 Length 17.5 in In distribution
IPN931041 Width 4.878 in In distribution
IPN927242 Length 10.5 in In distribution
IPN028330 Width 5.399 in In distribution
IPN028498 In distribution
IPN003143 Width 3.85 in In distribution
IPN927306 Length 7.8 in In distribution
IPN931053 Width 5.12 in In distribution
IPN927268 Width 5.12 in In distribution
IPN006987 Length 14 in In distribution
IPN927238 Length 8 in In distribution
IPN927263 Width 3.64 in In distribution
IPN921646 Length 16 in In distribution
IPN915180 Length 10.4 in In distribution
IPN921690 Length 8.1 in In distribution
IPN006985 Width 5.795 in In distribution
IPN028335 Length 6 in In distribution
IPN927254 Width 3.485 in In distribution
IPN914993 Length 8 in In distribution
IPN008564 Width 4.581 in In distribution
IPN008895 Length 10.75 in In distribution
IPN921666 Length 8 in In distribution
ME05RVLGTL In distribution
IPN921590 Length 17.5 in In distribution
IPN921597 Length 8 in In distribution
IPN028363 Length 10.93 in In distribution
IPN921706 In distribution
IPN914963 Width 5.12 in In distribution
IPN915177 Length 10.9 in In distribution
IPN028345 Length 7.881 in In distribution
IPN922085 Length 6 in In distribution
IPN028368 In distribution
IPN914944 Width 3.85 in In distribution
IPN912413 Width 5.765 in In distribution
IPN008506 Width 5.137 in In distribution
ME05LG In distribution
IPN915039 Length 11 in In distribution
IPN028319 Length 6 in In distribution
IPN915142 Length 8 in In distribution
IPN028239 Length 10.7 in In distribution
IPN028355 Length 11.1 in In distribution
IPN921594 Length 11.02 in In distribution
IPN914974 Length 8 in In distribution
IPN005040 Length 17.5 in In distribution
IPN915037 Length 8 in In distribution
IPN921628 Length 6 in In distribution
IPN921616 In distribution
IPN028281 Length 32 cm In distribution
IPN927295 Length 8 in In distribution
IPN008875 Length 10.7 in In distribution
IPN915173 Length 10.9 in In distribution
IPN028185 Width 4.668 in In distribution
IPN028343 Length 10.75 in In distribution
IPN028327 Width 4.372 in In distribution
IPN921663 Length 9.876 in In distribution
IPN008529 Length 7 in In distribution
IPN915117 Length 10.828 in In distribution
IPN028249 Length 8.1 in In distribution
IPN028285 Length 8 in In distribution
IPN028248 Length 10.828 in In distribution
IPN915005 Length 18.3 in In distribution
IPN003155 Length 10.5 in In distribution
IPN028293 Length 6 in In distribution
IPN931118 Width 5.795 in In distribution
IPN914942 Length 8 in In distribution
IPN028215 Width 4.42 in In distribution
IPN915086 Length 5.597 in In distribution
IPN927329 Length 8 in In distribution
IPN008887 Length 5.8 in In distribution
IPN039601 Length 11 in In distribution
IPN927277 Width 5.765 in In distribution
IPN921638 Length 48.5 cm In distribution
IPN915134 Length 7.881 in In distribution
IPN028210 Width 5.795 in In distribution
IPN921528 Length 10.9 in In distribution
IPN931097 Width 3.64 in In distribution
IPN009016 Length 11.02 in In distribution
IPN915088 Length 7.954 in In distribution
IPN914978 Length 11 in In distribution
IPN006968 Length 8 in In distribution
IPN914957 Width 4.27 in In distribution
IPN927328 Length 6 in In distribution
IPN931067 Width 5.765 in In distribution
IPN028263 Length 10.6 in In distribution
IPN922089 Width 3.64 in In distribution
IPN008577 Width 5.692 in In distribution
IPN004632 Height 5.2 in In distribution
IPN028230 Length 11 in In distribution
IPN028323 Length 9.876 in In distribution
IPN028225 Length 8 in In distribution
IPN931088 Length 6 in In distribution
IPN914965 Length 14 in In distribution
IPN921613 In distribution
IPN915021 Length 9.876 in In distribution
IPN028265 Width 5.09 in In distribution
IPN931095 Width 4.668 in In distribution
IPN006969 Length 8 in In distribution
IPN003129 Width 3.485 in In distribution
IPN914980 Length 11 in In distribution
IPN028297 Width 5.12 in In distribution
IPN004627 Width 5.12 in In distribution
IPN915169 Length 10.48 in In distribution
IPN028244 Length 5.8 in In distribution
IPN009014 Length 8 in In distribution
IPN927243 Length 8 in In distribution
IPN931096 Length 10.5 in In distribution
IPN004626 Length 14 in In distribution
IPN028234 Width 5.692 in In distribution
IPN931087 Width 3.485 in In distribution
IPN915087 Length 7.954 in In distribution
IPN927274 Width 5.765 in In distribution
IPN028294 Width 4.27 in In distribution
IPN921619 Length 6 in In distribution
IPN028271 Length 11.02 in In distribution
IPN927285 Length 8 in In distribution
IPN004611 Width 4.27 in In distribution
IPN921592 Length 32 cm In distribution
IPN028222 Length 9.876 in In distribution
IPN008510 Width 3.694 in In distribution
IPN028349 Length 8.1 in In distribution
IPN028238 Length 7.8 in In distribution
IPN008873 Length 10.7 in In distribution
IPN921709 In distribution
IPN003154 Width 4.432 in In distribution
IPN028197 Width 10.4 cm In distribution
IPN915045 Width 4.681 in In distribution
IPN915155 Length 10.5 in In distribution
IPN005020 Width 5.765 in In distribution
IPN008907 Length 7.785 in In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Teleflex Teleflex Medical LLC 61
Aesculap Aesculap AG 46
Ligaclip Ethicon Endo-Surgery, Inc. 29
Surgical Direct Surgical Direct, Inc. 28
Elmed Elmed, Inc. 23
RZ Medizintechnik GmbH RZ Medizintechnik Gmbh 19
Ambler Surgical Ambler Surgical, LLC 19
Europclip Ackermann Instrumente Gmbh 17
Lazic Peter Lazic Gmbh 15
Artisential Clip Applier Large LivsMed Inc. 14
Artisential Clip Applier Medium Large LivsMed Inc. 14
Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft 11

Showing 12 of 73. All products under Applier, Surgical, Clip

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated FDA class Root cause Reason Quantity Closed
2016-08-24 Class II Error in labeling Misbranded: Incorrect etching on the device. 49 units 2017-08-25
2003-05-21 Not classified Other Some stylets were not bent sufficiently during the packaging process to preclude them from sliding back into the cannula during shipment. 667 units 2005-01-31
2001-10-31 Not classified Other The flush port on some appliers was occluded with an epoxy resin during manufacturing. 66 units 2005-01-31

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer