BIPOLAR SUCTION COAGULATOR— 510(k) K960455
Substantially EquivalentKirwan Surgical Products, Inc.
FDA 510(k) clearance K960455 for BIPOLAR SUCTION COAGULATOR, Substantially Equivalent on 1996-02-27. Applicant: Kirwan Surgical Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Kirwan Surgical Products, Inc.
- Product code
- Code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rockland, MA, US
Recent devices under product code GEI
view allMore clearances from Kirwan Surgical Products, Inc.
view all- K100912 — DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE
- K070360 — KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40-3601
- K060915 — KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS
- K062659 — KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES
- K052203 — AURA 70 WATT BIPOLAR ELECTROSURGICAL COAGULATORS, MODELS 28-2000 AND 28-2600
Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
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.