Laparoscope Lens Shield Device (LENS)
FDA 510(k) K192891 · Medeon Biodesign, Inc.
510(k) numberK192891
Submission
- Device name
- Laparoscope Lens Shield Device (LENS)
- Applicant
- Medeon Biodesign, Inc.
Taipei, TW - Received
- October 10, 2019
- Decision date
- November 7, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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More from TroCare, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K200902 | ClickCleanGCJ · Special | 04/30/2020SE |
| K193652 | AbClose - Port Site Closure DeviceOCW · Traditional | 03/26/2020SE |
| K170103 | Laparoscope Lens Shield Device (LENS)GCJ · Special | 02/16/2017SE |
| K160117 | AbClose - Port Site Closure DeviceOCW · Traditional | 09/09/2016SE |
| K160172 | Laparoscope Lens Shield DeviceGCJ · Special | 04/21/2016SE |
| K151117 | Laparoscope Lens Shield DeviceGCJ · Traditional | 08/20/2015SE |
Questions and answers
When was Laparoscope Lens Shield Device (LENS) cleared by the FDA?
Laparoscope Lens Shield Device (LENS) (K192891) received a 510(k) decision of Substantially Equivalent on November 7, 2019, 28 days after the submission was received.
What is the product code of K192891?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.