FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AEON Retrieval Bag
K Number: K180114
·
Decision Mar 27, 2018
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
9
Review Days
70
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Basic Information
- Device Name
- AEON Retrieval Bag
- K Number
- K180114
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lexington Medical, Inc.
- Date Received
- January 16, 2018
- Decision Date
- March 27, 2018
- Product Code
- GCJ
- Advisory Committee
- Gastroenterology, Urology
- 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Lexington Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251482 | AEON Endoscopic Powered Stapler | Jul 11, 2025 | Substantially Equivalent |
| K234039 | AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260) | May 7, 2024 | 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 |
| K173443 | AEON Endoscopic Stapler | Feb 1, 2018 | Substantially Equivalent |
| K171589 | AEON Endoscopic Stapler | Nov 17, 2017 | Substantially Equivalent |