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
- 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 all- K262397 — CuratOR EX2742
- K260884 — UNIDRIVE Select System
- K260972 — OEV-271MUH LCD Monitor; OEV-321MUH LCD Monitor; OEV-431MUH LCD Monitor
- K261139 — VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)
- K253541 — EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)
More 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.