IRRIGATION/ASPIRATION TUBING SET— 510(k) K925621
Substantially EquivalentKirwan Surgical Products, Inc.
FDA 510(k) clearance K925621 for IRRIGATION/ASPIRATION TUBING SET, Substantially Equivalent on 1993-05-07. Applicant: Kirwan Surgical Products, Inc.. Device class: 1.
Clearance details
- Applicant
- Kirwan Surgical Products, Inc.
- Product code
- Code GAA
- Device class
- Class 1
- Regulation
- 21 CFR 878.4800
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rockland, MA, US
Recent devices under product code GAA
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 GAA
product code GAA- Malfunction
- 834
- Total
- 834
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.