Medrobotics Flex System
FDA 510(k) K150776 · Medrobotics Corporation
510(k) numberK150776
Submission
- Device name
- Medrobotics Flex System
- Applicant
- Medrobotics Corporation
Raynham, MA, US - Received
- March 24, 2015
- Decision date
- July 17, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EOB – Nasopharyngoscope (Flexible Or Rigid)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4760
- Specialty
- Ear, Nose, Throat
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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| K241731 | Outlook Surgical Versa One System (8900139)EOB · Traditional | Resnent, LLC | 08/11/2025SE |
| K243639 | Portare System (FA-001)EOB · Traditional | Grumpy Innovation, Inc. | 06/05/2025SE |
| K243380 | Visera S Video System Center Olympus OTV-S500 (Olympus OTV-S500)EOB · Traditional | Olympus Medical Systems Corporation | 03/03/2025SE |
| K234096 | MonoStereoEOB · Traditional | Medicaltek Co., Ltd. | 09/19/2024SE |
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| K232015 | ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0)EOB · Traditional | Atmos Medizintechnik GmbH & Co. KG | 08/03/2023SE |
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|---|---|---|
| K172796 | Flex Robotic System and Flex Transabdominal DriveHET · Traditional | 01/18/2018SE |
| K170453 | Medrobotics Flex Robotic SystemEOB · Traditional | 10/19/2017SE |
| K172036 | Medrobotics Flex Robotic SystemFDF · Special | 08/03/2017SE |
| K162330 | Flex Robotic System and Flex Colorectal DriveFDF · Traditional | 05/04/2017SE |
Questions and answers
When was Medrobotics Flex System cleared by the FDA?
Medrobotics Flex System (K150776) received a 510(k) decision of Substantially Equivalent on July 17, 2015, 115 days after the submission was received.
What is the product code of K150776?
The FDA product code is EOB – Nasopharyngoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4760.