Pilling
3 catalogue numbers from IPN007897, listed by Teleflex Medical LLC, United States, under Clip, Implantable. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
3catalogue numbers in this listing
7510(k) clearances naming this product code
18recalls on this code
Who Else Makes It
Concentrated in Shanghai (1), Beijing (1), Zhejiang (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Jiangsu Bana Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 4 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Beijing Zksk Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 38 |
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | FZP |
| Device type | Clip, Implantable |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4300 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2015-10-16 |
| Record revised | 2026-02-06 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Sizes | Length 0.15 to 0.17 in; width 0.254 in |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| IPN007897 | Length 0.17 in | 100 | In distribution |
| IPN007899 | Width 0.254 in | 100 | In distribution |
| IPN007898 | Width 0.254 in | 100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Weck | Teleflex Medical LLC | 321 |
| Teleflex | Teleflex Medical LLC | 57 |
| AtriClip™ LAA Exclusion System | Atricure, Inc. | 40 |
| Aesculap | Aesculap AG | 19 |
| Medline | Medline Industries, Inc. | 15 |
| AtriClip Flex•v | Atricure, Inc. | 12 |
| E-Pack | Ethicon, Inc. | 12 |
| AtriClip® Pro•v™ LAA Exclusion System | Atricure, Inc. | 12 |
| Titanium Ligation Clip | Vesocclude Medical, LLC | 11 |
| SLS-Clip | Vitalitec Surgical | 10 |
| SLS-Clip Vitalitec | Peters Surgical | 10 |
| MirusTM Ligating Clip | Meril Endo Surgery PVT. Ltd. | 10 |
Showing 12 of 70. All products under Clip, Implantable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251054 | 2025-07-03 |
| K232970 | 2024-01-12 |
| K230480 | 2023-04-28 |
| K161758 | 2016-09-07 |
| K133202 | 2013-12-03 |
| K132658 | 2013-11-27 |
| K062914 | 2006-11-02 |
Recalls
8 of these are 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.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2023-04-28 | Class II | Under Investigation by firm | Teleflex LLC is initiating this voluntary field corrective action because the clip cartridges for the affected product is missing a key feature that restricts the application of the clip to the applier. With this step feature missing on the | 146,606 units | |
| 2019-10-04 | Class II | Under Investigation by firm | Certain clip appliers have an increase in misloading and/or jamming related complaints that may be due to a discrepancy in the specification a component. Misloading and/or jamming may lead to clips falling out of the applier, clip breakage, | 34491 devices | |
| 2019-10-04 | Class II | Under Investigation by firm | Certain clip appliers have an increase in misloading and/or jamming related complaints that may be due to a discrepancy in the specification a component. Misloading and/or jamming may lead to clips falling out of the applier, clip breakage, | 4099 devices | |
| 2017-10-05 | Class II | Under Investigation by firm | The product has a non-conformity that may cause clips to mislead, jam or fall out of the applier. | 13,710 units | 2023-01-20 |
| 2016-02-02 | Class II | Nonconforming Material/Component | The clip in the applier may be missing a boss. A boss is the part of the clip that is used to hold the clip within the applier jaws prior to application. | 543 ea. | 2017-08-11 |
| 2014-12-03 | Class II | Labeling Change Control | The manufacturing dates and expiration dates were transposed on the Tyvek label. | 3180 units | 2017-11-24 |
| 2013-08-08 | Class II | Error in labeling | The manufacturing and expiration dates are not printed on the blister pack label. | 8,220 ea. | 2016-08-15 |
| 2012-09-25 | Class II | Packaging process control | Product is being recalled due to the possibility that the tray may contain pinholes, compromising product sterility. | 126 units | 2012-11-08 |
| 2008-08-22 | Not classified | Packaging process control | A hole in the sterile unit blister pack was detected that would compromise sterility. | 786036 (total pieces) | 2012-03-15 |
| 2008-08-22 | Not classified | Packaging process control | A hole in the sterile unit blister pack was detected that would compromise sterility. | 786036 (total pieces) | 2012-03-15 |
| 2008-08-22 | Not classified | Packaging process control | A hole in the sterile unit blister pack was detected that would compromise sterility. | 786036 (total pieces) | 2012-03-15 |
| 2008-08-22 | Not classified | Packaging process control | A hole in the sterile unit blister pack was detected that would compromise sterility. | 786036 (total pieces) | 2012-03-15 |
| 2008-08-22 | Not classified | Packaging process control | A hole in the sterile unit blister pack was detected that would compromise sterility. | 786036 (total pieces) | 2012-03-15 |
| 2006-04-12 | Not classified | Other | The Hem-o-lok ligating clips may become dislodged following ligation of the renal artery after laparoscopic donor nephrectomy. Hem-o-lok ligating clips are now contraindicated for use in ligating the renal artery during laparascopic nephre | 854,448 clips | 2007-11-14 |
| 2006-04-12 | Not classified | Other | The Hem-o-lok ligating clips may become dislodged following ligation of the renal artery after laparoscopic donor nephrectomy. Hem-o-lok ligating clips are now contraindicated for use in ligating the renal artery during laparascopic nephre | 3,656,100 clips | 2007-11-14 |
| 2006-04-12 | Not classified | Other | The Hem-o-lok ligating clips may become dislodged following ligation of the renal artery after laparoscopic donor nephrectomy. Hem-o-lok ligating clips are now contraindicated for use in ligating the renal artery during laparascopic nephre | 374,760 clips | 2007-11-14 |
| 2006-04-12 | Not classified | Other | The Hem-o-lok ligating clips may become dislodged following ligation of the renal artery after laparoscopic donor nephrectomy. Hem-o-lok ligating clips are now contraindicated for use in ligating the renal artery during laparascopic nephre | 5,573,400 clips | 2007-11-14 |
| 2004-01-23 | Not classified | Other | Malformation of the Hem-o-lok SMX clip. | 70 sales units | 2004-05-11 |
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.