FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260)
K Number: K234039
·
Decision May 7, 2024
Classifications
1
FEI Numbers
76
Registration Numbers
76
Same Product Code
41
Applicant Total
9
Review Days
138
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Basic Information
- Device Name
- AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260)
- K Number
- K234039
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lexington Medical, Inc.
- Date Received
- December 21, 2023
- Decision Date
- May 7, 2024
- Product Code
- GAG
- Advisory Committee
- General Hospital
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GAG | Stapler, Surgical | FDA class 2 | General Hospital |
Similar 510(k) Clearances
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Other Clearances by Lexington Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251482 | AEON Endoscopic Powered Stapler | Jul 11, 2025 | Substantially Equivalent |
| K222210 | AEON Endoscopic Stapler | Apr 21, 2023 | Substantially Equivalent |
| K201882 | AEON Endoscopic Stapler | Oct 9, 2020 | Substantially Equivalent |
| K192235 | AEON Laparoscopic Instruments | Oct 11, 2019 | Substantially Equivalent |
| K182380 | AEON Endoscopic Stapler | Nov 28, 2018 | Substantially Equivalent |
| K180114 | AEON Retrieval Bag | Mar 27, 2018 | Substantially Equivalent |
| K173443 | AEON Endoscopic Stapler | Feb 1, 2018 | Substantially Equivalent |
| K171589 | AEON Endoscopic Stapler | Nov 17, 2017 | Substantially Equivalent |