KII TROCAR SYSTEM— 510(k) K072674
Substantially EquivalentApplied Medical Resources Corp.
FDA 510(k) clearance K072674 for KII TROCAR SYSTEM, Substantially Equivalent on 2007-10-05. Applicant: Applied Medical Resources Corp.. Device class: 2.
Clearance details
- Applicant
- Applied Medical Resources Corp.
- 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
- Rancho Santa, CA, US
Recent devices under product code GCJ
view allMore clearances from Applied Medical Resources Corp.
view allAdverse 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 →
Recalls naming K072674
K-number listed on FDA's recall record- Z-2533-2017 — Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and Kii 5x55mm Optical Z-Thread Dual Pack (CTR14) trocars.
- Z-0644-2013 — Laparoscope, general; plastic surgery Used for general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K072674.
Data sourced from openFDA. This site is unofficial and independent of the FDA.