AEON Laparoscopic Instruments
FDA 510(k) K192235 · Lexington Medical, Inc.
510(k) numberK192235
Submission
- Device name
- AEON Laparoscopic Instruments
- Applicant
- Lexington Medical, Inc.
Billerica, MA, US - Received
- August 19, 2019
- Decision date
- October 11, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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| K251482 | AEON Endoscopic Powered StaplerGAG · Traditional | 07/11/2025SE |
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| K222210 | AEON Endoscopic StaplerGDW · Traditional | 04/21/2023SE |
| K201882 | AEON Endoscopic StaplerGDW · Traditional | 10/09/2020SE |
| K182380 | AEON Endoscopic StaplerGDW · Traditional | 11/28/2018SE |
| K180114 | AEON Retrieval BagGCJ · Traditional | 03/27/2018SE |
| K173443 | AEON Endoscopic StaplerGDW · Traditional | 02/01/2018SE |
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Questions and answers
When was AEON Laparoscopic Instruments cleared by the FDA?
AEON Laparoscopic Instruments (K192235) received a 510(k) decision of Substantially Equivalent on October 11, 2019, 53 days after the submission was received.
What is the product code of K192235?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.