Disposable Laparoscope Trocar— 510(k) K201641
Substantially EquivalentBeijing Biosis Healing Biolog Ical Technology Co., Ltd.
FDA 510(k) clearance K201641 for Disposable Laparoscope Trocar, Substantially Equivalent on 2020-08-06. Applicant: Beijing Biosis Healing Biolog Ical Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Beijing Biosis Healing Biolog Ical Technology Co., Ltd.
- Product code
- Product code GCJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beijing, CN
Recent devices under product code GCJ
view allMore clearances from Beijing Biosis Healing Biolog Ical Technology Co., Ltd.
view all- K231513 — Oral Matrix
- K203622 — Medical Gloves
- K201639 — Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads
- K202844 — Medical Surgical Gowns
- K202029 — Medical Surgical Mask
Adverse events under product code GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
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.