# K241502: P-Scope

- Pathway: 510(k) (Traditional)
- Applicant: Oui Medical, Inc.
- Decided: Jul 24, 2024 after 57 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: 5 generations back to K923982 (1993). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220872: Saberscope5 Laparoscope, Xenocor, Inc. (2022) Summary page 4.
- K211250: VisionPort System, New View Surgical, Inc. (2021) Summary page 4.

## Indications for use
P-Scope is intended to be used in diagnostic and therapeutic procedures for endoscopy within the peritoneal cavities including the female reproductive organs.

Source page: https://510kreport.com/device/K241502
Methodology: https://510kreport.com/methodology