Disposable Endoscopic Hemoclip— 510(k) K222146
Substantially EquivalentJiangsu Vedkang Medical Science and Technology Co., Ltd.
FDA 510(k) clearance K222146 for Disposable Endoscopic Hemoclip, Substantially Equivalent on 2023-03-28. Applicant: Jiangsu Vedkang Medical Science and Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Jiangsu Vedkang Medical Science and Technology Co., Ltd.
- Product code
- Code PKL
- Device class
- Class 2
- Regulation
- 21 CFR 876.4400
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Changzhou, CN
Recent devices under product code PKL
view allMore clearances from Jiangsu Vedkang Medical Science and Technology Co., Ltd.
view all- K232825 — Disposable Sphincterotome
- K232752 — Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C)
- K232245 — VedDilator ^TM (3-Stage Balloon Dilation Catheter)
- K230598 — Stone Extraction Baskets
- K220089 — Disposable Polyp Snare
Adverse events under product code PKL
product code PKL- Death
- 9
- Injury
- 489
- Malfunction
- 4,698
- Other
- 1
- Total
- 5,197
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.