# K192691: PatCom Single-Use Introducer

- Pathway: 510(k) (Traditional)
- Applicant: H&A Mui Enterprises, Inc.
- Decided: Feb 21, 2020 after 148 days
- Product code: FED (Endoscopic Access Overtube, Gastroenterology-Urology)
- 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: 6 generations back to K993704 (2000). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100081: Enteroscopy Overtube, Model 00712140, United States Endoscopy Group, Inc. (2010) Summary page 5.

## Indications for use
The Single-Use Introducer is used for patient esophageal intubation to guide the catheters and tubes via the nasal or oral cavity. It is to be used in conjunction with endoscopes to allow visualization of the placement process. The Single-Use Introducer is to be used in a hospital or clinical setting and under the supervision of a qualified healthcare professional who has received professional training in using the equipment. The Single-Use Introducer is provided non-sterile, and is intended to be non-reusable. The Single-Use Introducer is for transient use (under 24 hrs), and will come in direct contact with the patient’s mucosal lining.

Source page: https://510kreport.com/device/K192691
Methodology: https://510kreport.com/methodology