Data / Medical devices / United States / Lexington Medical, Inc.
Lexington Medical, Inc.: FDA-registered device maker in Bedford, MA, United States, 7 510(k) clearances
Lexington Medical, Inc. is registered with the FDA (registration 3012998149) in Bedford, MA, United States. It lists 3 device types. The FDA files 7 510(k) clearances under its listings, the newest dated May 7, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012998149
- Address
- 23 Crosby Drive, Bedford, MA, United States, 01730
- Owner or operator
- Lexington Medical, Inc. (10054419)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- October 2, 2017
- Registered through
- 2026
- Brand names listed
- AEON Endoscopic Powered Stapler, AEON Endoscopic Stapler, AEON Retrieval Bag, AEON Endoscopic Stapler
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Staple, Implantable | GDW | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Stapler, Surgical | GAG | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 7, 2024 | K234039 | AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260) | GAG | Substantially Equivalent | Lexington Medical, Inc. | accessdata.fda.gov |
| April 21, 2023 | K222210 | AEON Endoscopic Stapler | GDW | Substantially Equivalent | Lexington Medical, Inc. | accessdata.fda.gov |
| October 9, 2020 | K201882 | AEON Endoscopic Stapler | GDW | Substantially Equivalent | Lexington Medical, Inc. | accessdata.fda.gov |
| November 28, 2018 | K182380 | AEON Endoscopic Stapler | GDW | Substantially Equivalent | Lexington Medical, Inc. | accessdata.fda.gov |
| March 27, 2018 | K180114 | AEON Retrieval Bag | GCJ | Substantially Equivalent | Lexington Medical, Inc. | accessdata.fda.gov |
| November 17, 2017 | K171589 | AEON Endoscopic Stapler | GDW | Substantially Equivalent | Lexington Medical, Inc. | accessdata.fda.gov |
| February 9, 2017 | K162710 | Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload | GDW | Substantially Equivalent | Tgs Medical Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Stapler, Surgical
- All makers of Staple, Implantable
- All makers of Laparoscope, General & Plastic Surgery
Updated May 7, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.