AEON Endoscopic Powered Stapler (3 models)— 510(k) K234039
Substantially EquivalentLexington Medical, Inc.
FDA 510(k) clearance K234039 for AEON Endoscopic Powered Stapler (3 models), Substantially Equivalent on 2024-05-07. Applicant: Lexington Medical, Inc.. Device class: 2.
Clearance details
- Device name as filed
- AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260)
- Applicant
- Lexington Medical, Inc.
- Product code
- Code GAG
- Device class
- Class 2
- Regulation
- 21 CFR 878.4740
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bedford, MA, US
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More clearances from Lexington Medical, Inc.
view allAdverse events under product code GAG
product code GAG- Death
- 23
- Injury
- 394
- Malfunction
- 2,304
- Other
- 6
- Total
- 2,727
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.