# K161838: Xenocor Xenoscope Laparoscopic System

- Pathway: 510(k) (Traditional)
- Applicant: Xenocor, Inc.
- Decided: Sep 26, 2016 after 83 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K923982 (1993). 4 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935279: Karl Storz Hopkins I Rigid Autoclavable Telescope, Karl Storz Hopkins II Rigid Autoclavable Telescope, KARL STORZ Endoscopy-America, Inc. (1994) Summary page 4.
- K993045: Bariatric Laparoscope, Model 367, Stryker Endoscopy (1999) Summary page 4.
- K150633: ULTRA Telescopes, Olympus Winter & Ibe GmbH (2015) Summary page 4.

## Most influential descendants
- K193315: Xenocor Articulating Xenoscope Laparoscope (2020), 3 descendants of its own
- K220872: Saberscope5 Laparoscope (2022), 2 descendants of its own
- K211250: VisionPort System (2021), 1 descendant of its own
- K260177: Saberscope™ Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1) (2026), 0 descendants of its own
- K241502: P-Scope (2024), 0 descendants of its own

## Indications for use
The Xenoscope™ is intended to be used in diagnostic and therapeutic procedures for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs.

Source page: https://510kreport.com/device/K161838
Methodology: https://510kreport.com/methodology