INTELLIGENT ARTICULATING ENDOSCOPIC LINEAR CUTTER REVERSE WITH RELOADS— 510(k) K083527
Substantially EquivalentPower Medical Interventions, Inc.
FDA 510(k) clearance K083527 for INTELLIGENT ARTICULATING ENDOSCOPIC LINEAR CUTTER REVERSE WITH RELOADS, Substantially Equivalent on 2008-12-18. Applicant: Power Medical Interventions, Inc.. Device class: 2.
Clearance details
- Applicant
- Power Medical Interventions, Inc.
- Product code
- Code GDW
- Device class
- Class 2
- Regulation
- 21 CFR 878.4750
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Langhorne, PA, US
Recent devices under product code GDW
view allMore clearances from Power Medical Interventions, Inc.
view all- K091215 — INTELLIGENT POWER UNIT, INTELLIGENT CONSOLE, INTELLIGENT DELIVERY SYSTEM, INTELLIGENT SURGICAL INSTRUMENT
- K081826 — INTELLIGENT STRAIGHT AND ARTICULAR ENDOSCOPIC LINEAR CUTTERS, VASCULAR WITH RELOADS, MODELS I30V, I45V, 160V, IR30V
- K073001 — IDRIVES, IDRIVEC, IDRIVEF
- K073148 — IDRIVES, IDRIVEC, IDRIVEF WITH VASCULAR INDICATIONS
- K071708 — I45, I45S, I60, AND I60S
Adverse events under product code GDW
product code GDW- Death
- 450
- Injury
- 12,684
- Malfunction
- 68,730
- Other
- 6
- Total
- 81,870
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.