POWER CIRCULAR STAPLER DIGITAL LOADING UNIT WITH AND WITHOUT SHEATH— 510(k) K061649
Substantially EquivalentPower Medical Interventions, Inc.
FDA 510(k) clearance K061649 for POWER CIRCULAR STAPLER DIGITAL LOADING UNIT WITH AND WITHOUT SHEATH, Substantially Equivalent on 2006-09-01. 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
- K083527 — INTELLIGENT ARTICULATING ENDOSCOPIC LINEAR CUTTER REVERSE WITH RELOADS
- 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
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.