Xenocor Articulating Xenoscope Laparoscope
FDA 510(k) K193315 · Xenocor, Inc.
510(k) numberK193315
Submission
- Device name
- Xenocor Articulating Xenoscope Laparoscope
- Applicant
- Xenocor, Inc.
Salt Lake City, UT, US - Received
- November 29, 2019
- Decision date
- January 27, 2020
- 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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| K262397 | CuratOR EX2742GCJ · Traditional | Eizo Corporation | 09/11/2026SE |
| K260884 | UNIDRIVE Select SystemGCJ · Traditional | Karl Storz SE & CO. KG | 09/01/2026SE |
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| K261139 | VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)GCJ · Traditional | Freyja Healthcare, LLC | 08/13/2026SE |
| K253541 | EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ…GCJ · Traditional | Medical Impact | 07/24/2026SE |
| K261614 | LED LCD Monitor (OEV-271H)GCJ · Traditional | Lg Electronics.Inc | 07/17/2026SE |
| K261249 | Universal Seal (5-12 mm)GCJ · Traditional | Intuitive Surgical, Inc. | 07/14/2026SE |
| K260710 | FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm…GCJ · Traditional | FloShield, Inc. | 06/11/2026SE |
| K260414 | Tech-Image Video Endoscope SystemGCJ · Traditional | Tech-Image CO., LTD. | 06/10/2026SE |
| K253994 | TroKit Laparoscope Lens WiperGCJ · Traditional | TroCare, LLC | 06/04/2026SE |
More from TroCare, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K260177 | Saberscope Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1)GCJ · Special | 02/12/2026SE |
| K220872 | Saberscope5 LaparoscopeGCJ · Special | 04/20/2022SE |
| K171344 | Xenocor Xenoscope Laparoscopic SystemGCJ · Special | 06/01/2017SE |
| K161838 | Xenocor Xenoscope Laparoscopic SystemGCJ · Traditional | 09/26/2016SE |
Questions and answers
When was Xenocor Articulating Xenoscope Laparoscope cleared by the FDA?
Xenocor Articulating Xenoscope Laparoscope (K193315) received a 510(k) decision of Substantially Equivalent on January 27, 2020, 59 days after the submission was received.
What is the product code of K193315?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.