Applier, Hemostatic Clip
FDA product code HBT · Class I (low risk) · 21 CFR 878.4800 · General, Plastic Surgery
4510(k) clearances
0PMA approvals
5recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K924929 | Reflex(R) EcaHBT · Traditional | Richard-Allan Medical | 07/21/1993SE |
| K896262 | Titanium Ligating ClipsHBT · Traditional | Richard-Allan Medical Ind., Inc. | 01/02/1990SE |
| K862696 | Temporary Hemo Clip, 07-096-01/02 & Apply ForcepHBT · Traditional | Downs Surgical , Ltd. | 07/30/1986SE |
| K800318 | Doubletime 2-TIPPED Appliers for HemocliHBT · Traditional | Edward Weck, Inc. | 03/10/1980SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3042-2018 Class II | AnastoClip GC Closure System, REF# 4007-08 a closure system designed to penetrate the…The wrong instructions for use (IFU) were supplied with the AnastoClip GC closure system. The IFU provided… | LeMaitre Vascular, Inc. | 06/19/2018Terminated |
| Z-1209-2014 Class II | Reusable Clip Applier Manufactured by AtriCure, Inc., 6217 Centre Park Drive, West…The firm was notified by a customer of a cracked spring in the handle of the RCD1 device. | Atricure Inc | 01/23/2014Terminated |
| Z-0165-2011 | LeMaitre Vascular AnastoClip GC Vessel Closure System-Large Size Models: 4007-03 Large…Mislabeled size on external packaging: The contents section listed on the Tyvek lid labels of the Medium and… | Lemaitre Vascular, Inc. | 09/22/2010Terminated |
| Z-0164-2011 | LeMaitre Vascular AnastoClip GC Vessel Closure System-Medium Size Models: 4007-02 Medium…Mislabeled size on external packaging: The contents section listed on the Tyvek lid labels of the Medium and… | Lemaitre Vascular, Inc. | 09/22/2010Terminated |
| Z-0564-2009 | Multi-Clip Applier Model #'s: APPCA080 AUT134031 AUT134046 AUT134051 AUT134053 AUT176625…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | Sterilmed Inc | 08/08/2008Terminated |