510(k) K251054
- Device
- Hem-o-lok? PurplePlus? Large Polymer Ligating Clips
- Applicant
- Teleflex Medical
- 510(k) number
- K251054
- Product code
- FZP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-07-03
- Date received
- 2025-04-04
- Regulation
- 878.4300
- Classification name
- Clip, Implantable
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Hope West
- Address
- 3015 Carrington Mill Bld Morrisville NC US 27560 27560
FDA Registration Numbers#
- 1614993
- 3024021261
- 1423537
- 3003898360
- 2029275
- 2024024
- 3010605922
- 9680340
- 9610612
- 3021008900
- 1220948
- 2431166
- 3005636544
- 3016248634
- 3020965506
- 3017196117
- 1047843
- 3002907620
- 9616088
- 3018094310
- 3008843439
- 3015895045
- 1319639
- 3008492462
- 1018233
- 1054241
- 2647580
- 1018470
- 3011706110
- 3017636737
- 8010273
- 3015185328
- 1219930
- 3008729892
- 3001650400
- 3008989837
- 3013188547
- 3014479313
- 3015183635
- 3017102971
- 1055236
- 2020394
- 1020279
- 3004111573
- 1825034
- 3010408671
- 1527736
- 2953359
- 3015453963
- 3009380063
- 8030607
- 3009763019
- 1061124
- 3010383847
- 1650907
- 3004365956
- 3004060107
- 3016678045
- 3015207155
- 1836161
- 2022435
- 3030733800
- 3007205024
- 1043214
- 3004014152
- 2320762
- 3004215117
- 2246552
- 2210968
- 2916714
- 3008744062
- 1417592
- 3011989923
- 9710649
- 3008236846
- 3021632375
- 3013176080
- 3008770252
- 3008992312
Source Documents#
Other 510(k) Records For Product Code FZP#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253903 | InnoClip Disposable Clip Applier | Taiwan Surgical Corporation | 2025-12-22 |
| K253781 | InnoClip Clip Applier | Taiwan Surgical Corporation | 2025-12-22 |
| K250643 | Disposable Polymer Ligation Clips | Hangzhou Kangji Medical Instrument Co., Ltd. | 2025-11-20 |
| K242541 | GEM ZIPCLIP | Synovis Micro Companies Alliance A Subsidiary of Baxter Int | 2025-01-15 |
| K221495 | SOLID CLIP™ Single Use Clip Applier | Medscope Biotech Co., Ltd. | 2024-07-18 |
| K232970 | Hem-o-lok® Ligating Clips | Teleflex Medical | 2024-01-12 |
| K230966 | angiOCCLUDE Ligating Clips | A2 Medical Systems, LLC | 2023-09-19 |
| K232313 | LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320) | Ethicon Endo Surgery, LLC | 2023-08-29 |
| K230480 | Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML) | Teleflex Medical | 2023-04-28 |
| K213813 | DuraFuse Clip and Applier System | Neuramedica, Inc. | 2022-07-22 |
| K220006 | angioLOCK Polymer Ligating Clip | A2 Medical Systems, LLC | 2022-03-02 |
| K202994 | InnoClip Disposable Clip Applier, InnoClip Clip Applier | Taiwan Surgical Corporation | 2022-01-04 |
| K200166 | Mirus Ligating Clip, Mirus Ligating Clip Applier | M/s. Meril Endo Surgery Private Limited. | 2020-11-23 |
| K202124 | Aesculap PAS-Port Proximal Anastomosis System | Aesculap, Inc. | 2020-09-02 |
| K192711 | Dannik Titanium Ligation Clip | Dannik | 2019-12-20 |