# K960194: Myelotec Myeloscope

- Pathway: 510(k) (Traditional)
- Applicant: Myelotec, Inc.
- Decided: Sep 4, 1996 after 232 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K930191 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930191: Danek (TM) Spinal Epidural Endoscopic SY, Sofamor Danek Mfg., Inc. (1995) Summary page 4.

## Cited in the summary but kept off the family tree
- K913129: Angiolaz Angioscope Catheter, Angiolaz, Inc. (1991). Our OCR of the scanned summary read K913129, FDA’s number for Angiolaz Angioscope Catheter (Angiolaz, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Ultra-Vu Endoscope Systems”. Kept off the family tree. Summary page 4.

## Recalls of this device
- Dec 19, 2007 · Not classified · Z-0586-2008: 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
The Myeloscope is intended to be used by physicians for the illumination and visualization of tissues of the epidural space in the lumbar and sacral spine for the purpose of assisting in the diagnosis of disease.

Source page: https://510kreport.com/device/K960194
Methodology: https://510kreport.com/methodology