# K963023: Ultrasound Gastroscope GF Type UM30P

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Feb 7, 1997 after 186 days
- Product code: FDS (Gastroscope And Accessories, Flexible/Rigid)
- 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: 1 generation back to K926514 (1993). 1 ancestor in all.
88 later devices descend from it; 2 cite it directly.
1 of 90 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K926514: Endoscopic Ultrasound System Type 20, Olympus Corp. (1993) Summary page 1.

## Most influential descendants
- K010591: Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound Center (2001), 59 descendants of its own
- K031347: Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8 (2003), 44 descendants of its own
- K042140: Olympus BF Type UC160-OL8 (2004), 43 descendants of its own
- K050503: Single Use Aspiration Needle NA-201SX-4022 (2005), 28 descendants of its own
- K994373: Hdi 1500/SA 8800 Ultrasound System with Multiplane Transesophageal Ultrasound Transducer (MTP7-4) (2000), 27 descendants of its own

## Indications for use
The Olympus GF-UM30P Ultrasonic Endoscope is intended to be used in combination with the Ultrasound System, EU-M20 or EU-M30, for endoscopic ultrasound irnaging of the gastrointestinal tract wall, billiary and pancreatic duct, and surrounding organs. This instrument also provide for Endoscopic Ultrasound (EUS) guided fine needle aspiration (FNA) to acquire submucosal tissue.

Source page: https://510kreport.com/device/K963023
Methodology: https://510kreport.com/methodology