SURGICAL TROCAR— 510(k) K911462
Substantially EquivalentApplied Medical
FDA 510(k) clearance K911462 for SURGICAL TROCAR, Substantially Equivalent on 1991-04-22. Applicant: Applied Medical. Device class: 2.
Clearance details
- Applicant
- Applied Medical
- Product code
- Code DRC
- Device class
- Class 2
- Regulation
- 21 CFR 870.1390
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bolton, MA, US
Recent devices under product code DRC
view allMore clearances from Applied Medical
view allAdverse events under product code DRC
product code DRC- Death
- 28
- Injury
- 412
- Total
- 440
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 K911462
K-number listed on FDA's recall record- Z-1584-2018 — 5 mm Apple-Hunt Secondary Cannula/Pyramidal Tip Trocar - extended length (5 count); Model Number 900-840 Product Usage: The Apple-Hunt Secondary Cannulas are indicated for use in laparoscopic surgical procedures to provide a pathway for the introduction of endoscopic surgical instruments and allow for maintenance of pneumoperitoneum. For uninhibited laparoscopic access, the Apple-Hunt Cannula/Trocar provides greater instrument maneuverability while maintaining an airtight seal -with no bulky external valves, fittings, or housings. The ergonomic trocar design is simple to use and features a smooth cannula/trocar transition for easier sleeve insertion and reduced risk of patient injury.
- Z-0147-2015 — Blunt Hurd Cannula Blunt Tip 10 mm with 5 mm Reducer simplifies open laparoscopy.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K911462.
Data sourced from openFDA. This site is unofficial and independent of the FDA.