Niceloop
NiceLoop White/Green Braided PTFE impregnated Polyester Size 5 24" Looped KAC-25 Needle Tornier
6manufacturers in China registered for this device type
12catalogue numbers in this listing
9510(k) clearances naming this product code
8recalls on this code
Who Else Makes It
Concentrated in Shanghai (2), Shandong (2), Fujian (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Shandong Haidike Medical Products Co., Ltd. | Heze | Shandong | Manufacturer | 22 |
| Xiamen Zhiyuan Medical Technology Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 22 |
| Foosin Medical Supplies Inc.ltd | Weihai | Shandong | Manufacturer | 8 |
| ARC Medical Supplies (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | GAT |
| Device type | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5000 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2015-10-16 |
| Record revised | 2025-04-28 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Box, box of 12 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN000979 | Suture Length 24″, Needle Length 1.951″ | In distribution |
| IPN000980 | Suture Length 24″, Needle Length 1.951″ | In distribution |
| IPN000983 | Suture Length 24″, Needle Length 1.951″ | In distribution |
| IPN000982 | Suture Length 24″, Needle Length 1.951″ | In distribution |
| IPN000984 | Suture Length 24″, Needle Length 1.951″ | In distribution |
| IPN000981 | Suture Length 24″, Needle Length 1.951″ | In distribution |
| IPN000981 | Suture Length 24″, Needle Length 1.951″ | In distribution |
| IPN000979 | Suture Length 24″, Needle Length 1.951″ | In distribution |
| IPN000982 | Suture Length 24″, Needle Length 1.951″ | In distribution |
| IPN000984 | Suture Length 24″, Needle Length 1.951″ | In distribution |
| IPN000980 | Suture Length 24″, Needle Length 1.951″ | In distribution |
| IPN000983 | Suture Length 24″, Needle Length 1.951″ | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Premicron | B Braun Surgical SA | 1,377 |
| Deknatel | Teleflex Medical LLC | 1,198 |
| FlexiGRAFT® | LifeNet Health | 992 |
| DemeBOND | Demetech Corp. | 939 |
| Ti-Cron | Covidien LP | 482 |
| HS FIber | Riverpoint Medical LLC | 413 |
| Ethibond Excel | Ethicon, Inc. | 383 |
| Arthrex® | Arthrex, Inc. | 307 |
| Dagrofil | B Braun Surgical SA | 195 |
| WEGO-Polyester Nonabsorbable Surgical Suture With Needle | Foosin Medical Supplies Inc.ltd | 175 |
| Cardioxyl ® | Peters Surgical | 162 |
| Silkam | B Braun Surgical SA | 150 |
Showing 12 of 275. All products under Suture, Nonabsorbable, Synthetic, Polyethylene
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260775 | 2026-05-06 |
| K192490 | 2020-03-30 |
| K191268 | 2019-06-11 |
| K181774 | 2018-10-10 |
| K172016 | 2017-10-03 |
| K100506 | 2010-03-10 |
| K063778 | 2007-02-09 |
| K040472 | 2004-03-15 |
| K033654 | 2004-01-15 |
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 |
|---|---|---|---|---|---|
| 2014-03-11 | Class II | Employee error | The products are being recalled because they did not meet minimum needle attachment strength requirements. | Total 32,271 ea. | 2017-08-15 |
| 2014-03-11 | Class II | Employee error | The products are being recalled because they did not meet minimum needle attachment strength requirements. | Total 32,271 ea. | 2017-08-15 |
| 2014-03-11 | Class II | Employee error | The products are being recalled because they did not meet minimum needle attachment strength requirements. | Total 32,271 ea. | 2017-08-15 |
| 2014-03-11 | Class II | Employee error | Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use. | 32,271 ea. | 2017-08-14 |
| 2014-03-11 | Class II | Employee error | The products are being recalled because they did not meet minimum needle attachment strength requirements. | Total 32,271 ea. | 2017-08-15 |
| 2014-03-11 | Class II | Employee error | Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use. | 32,271 ea. | 2017-08-14 |
| 2014-03-11 | Class II | Employee error | The products are being recalled because they did not meet minimum needle attachment strength requirements. | Total 32,271 ea. | 2017-08-15 |
| 2014-03-11 | Class II | Employee error | The products are being recalled because they did not meet minimum needle attachment strength requirements. | Total 32,271 ea. | 2017-08-15 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| N16374 | 1986-01-23 | PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S | Ethicon, Inc. |
| P810028 | 1984-12-17 | DEKLENE(TM) | Deknatel, Inc. |
| N17825 | 1981-09-24 | SURGILENE | Davis & Geck, Inc. |
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.