Alexis Contained Extraction System
FDA 510(k) K211043 · Applied Medical Resources Corporation
510(k) numberK211043
Submission
- Device name
- Alexis Contained Extraction System
- Applicant
- Applied Medical Resources Corporation
Rancho Santa, CA, US - Received
- April 8, 2021
- Decision date
- March 31, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GCJ – Laparoscope, General & Plastic Surgery
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
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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| K260414 | Tech-Image Video Endoscope SystemGCJ · Traditional | Tech-Image CO., LTD. | 06/10/2026SE |
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Questions and answers
When was Alexis Contained Extraction System cleared by the FDA?
Alexis Contained Extraction System (K211043) received a 510(k) decision of Substantially Equivalent on March 31, 2022, 357 days after the submission was received.
What is the product code of K211043?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.