NMJClass IIImplant
Clip, Implantable, Reprocessed
General, Plastic Surgery · 21 CFR 878.4300
The "implantable clip, reprocessed" is intended to connect internal tissues to aid in healing. It is not absorbable. This device is indicated for reuse/reprocessing. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
MDR events257All time
Recalls0All time
Registered firms1Currently listed
510(k) clearances1All time
Recent MDR events
257 adverse event reports on file
- MULTI CLIP APPLIER LIGACLIP SMALL CLIPSDec 17, 2021MalfunctionSterilmed, Inc.2134070-2021-00035
- MULTI CLIP APPLIER LIGACLIP MEDIUM CLIPSDec 17, 2021MalfunctionSterilmed, Inc.2134070-2021-00036
- MULTI CLIP APPLIER LIGACLIP MEDIUM CLIPSDec 17, 2021MalfunctionSterilmed, Inc.2134070-2021-00034
- CLIP APPLIERS LIGACLIP MULTIPLE CLIP APPLIERS LG CLIPSDec 17, 2021MalfunctionSterilmed, Inc.2134070-2021-00033
- LIGACLIPNov 22, 2021MalfunctionSterilmed, Inc.12851433
- MULTIPLE CLIP APPLIER LIGACLIPNov 22, 2021MalfunctionSterilmed, Inc.2134070-2021-00026
- MULTIPLE CLIP APPLIER LIGACLIPNov 22, 2021MalfunctionSterilmed, Inc.2134070-2021-00025
- MULTI CLIP APPLIER LIGACLIP ERCA ROTATING MEDIUM/LARGE CLIPSJun 16, 2021InjurySterilmed, Inc.2134070-2021-00008
- MULTI CLIP APPLIER LIGACLIP ERCA ROTATING MEDIUM/LARGE CLIPSJun 16, 2021InjurySterilmed, Inc.2134070-2021-00009
- MULTI CLIP APPLIER LIGACLIP ERCA ROTATING MEDIUM/LARGE CLIPSJun 16, 2021InjurySterilmed, Inc.2134070-2021-00010
Event type breakdown
Malfunction230
Injury25
Unspecified1
Death1
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
1 firms currently registered for this product code
510(k) clearances
1 clearances for this product code