# K201113: Resascope RS-01/B

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Medical Systems Group Srl
- Decided: Dec 21, 2020 after 238 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K954584 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980734: Myelotec Video Guided Catheter, Myelotec, Inc. (1998) Summary page 4.

## Indications for use
When used with a fibreoptic endoscope, Resascope is a video guided catheter intended to be used in the lumbar and sacral spine for observing epidural anatomy, pathology and delivery of drugs approved for epidural indications

Source page: https://510kreport.com/device/K201113
Methodology: https://510kreport.com/methodology