Catheter, Drainage, Intraoral/extraoral
General, Plastic Surgery · 21 CFR 878.4200
To allow continuous drainage of saliva and/or fluid irrigation of the salivary duct as well as assisting in maintaining duct patency during the healing process following removal of salivary gland stones for temporary insertion into the salivary gland, whether orally or through the cheek following endoscopic or surgical removal of salivary gland stones
Recent MDR events
4 adverse event reports on file
- SKATER ALL-PURPOSE DRAINAGE CATHETER LOCKING PIGTAIL 8FR X 25CMFeb 14, 2023MalfunctionArgon Medical Devices0001625425-2023-00967
- SKATER SINGLE STEP DRAINAGE SET-LOCKING 8F X 25CMFeb 1, 2023MalfunctionArgon Medical Devices0001625425-2023-00952
- SKATER DRAINAGE CATHETER - LOCKING PIGTAIL 8F X 25CMJan 3, 2023MalfunctionArgon Medical Devices0001625425-2023-00918
- KOLENDA SALIVARY ACCESS INTRODUCER SET SDASApr 14, 2017InjuryCook Inc1820334-2017-00672
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
8 firms currently registered for this product code
C2dx, Inc.
Schoolcraft, MI, US
Dentimed Sao Joao
Sunrise, FL, US
Shandong Zhushi Pharmaceutical Group Co., Ltd
Heze Shandong, CN
Karl Storz Endoscopy-america, Inc.
El Segundo, CA, US
Hangzhou Fushan Medical Appliance Co., Ltd.
Hangzhou City Zhejiang, CN
Hynaut Health Technology Co., Ltd.
Qingdao Shandong, CN
Andersen Scientific, Inc.
Morrisville, NC, US
Falcon Surgical Co. (pvt.) Ltd.
Sialkot Punjab, PK
510(k) clearances
1 clearances for this product code