INTEGRA Wound Matrix (Macro-Channels)— 510(k) K210128
Substantially EquivalentIntegra LifeSciences Corporation
FDA 510(k) clearance K210128 for INTEGRA Wound Matrix (Macro-Channels), Substantially Equivalent on 2021-10-08. Applicant: Integra LifeSciences Corporation. Device class: Unclassified.
Clearance details
- Applicant
- Integra LifeSciences Corporation
- Product code
- Code KGN
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Princeton, NJ, US
Recent devices under product code KGN
view allMore clearances from Integra LifeSciences Corporation
view all- K251162 — CUSA® Clarity Ultrasonic Surgical Aspirator System
- K250752 — AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)
- K240493 — CUSA® Clarity Ultrasonic Surgical Aspirator System
- K230427 — CUSA Clarity Ultrasonic Surgical Aspirator System
- K221835 — CUSA Clarity Ultrasonic Surgical Aspirator System
Adverse events under product code KGN
product code KGN- Other
- 2
- Total
- 2
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.