# K980734: Myelotec Video Guided Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Myelotec, Inc.
- Decided: Aug 11, 1998 after 167 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K954584 (1996). 1 ancestor in all.
4 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954584: Racz Epidural Catheter, Medic Evaluation Devices & Instruments Corp. (1996) Summary page 1.

## Most influential descendants
- K150789: Spinaut-E, Spinaut-I (2016), 1 descendant of its own
- K241410: EDEN ControlCath (2025), 0 descendants of its own
- K201113: Resascope RS-01/B (2020), 0 descendants of its own
- K151268: Spinaut-V, Spinaut-S, Spinaut-I (2016), 0 descendants of its own

## Recalls of this device
- Mar 2, 2017 · Class II · Z-2779-2017: Obstructed/blocked port from defective VGC Access Port Body component.
- Dec 19, 2007 · Not classified · Z-0587-2008: Incorrect Labeling information: Product may contain inappropriate information in its label insert that refers to the product's use with energy delivering instrumentation.

## Indications for use
when used with a fiberoptic endoscope, this device can be used for observing epidural anatomy, pathology and delivery of drugs approved for epidural indications.

Source page: https://510kreport.com/device/K980734
Methodology: https://510kreport.com/methodology