# K133316: Spirol  Block (19 GA. Open End Models), (20 GA. Open End Models), (19 GA. Closed End Models), (20 GA. Closed End Models)

- Pathway: 510(k) (Traditional)
- Applicant: Epimed International, Inc.
- Decided: May 28, 2014 after 212 days
- Product code: BSO (Catheter, Conduction, Anesthetic)
- Device class: 2
- Regulation: 21 CFR 868.5120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K801912 (1980). 11 ancestors in all.
No later device cites it as a predicate yet.
5 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981329: Feth-R-Kath, Epimed International, Inc. (1998) Summary page 1.
- K122027: Arrow Flexblock Continuous Peripheral Nerve Block Catheter, Arrow International, Inc. (2012) Summary page 1.

## Indications for use
The Spirol® Block Continuous Peripheral Nerve Block Catheter permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques including upper extremity, lower extremity, abdominal and paravertebral locations for periods not exceeding 72 hours.

Source page: https://510kreport.com/device/K133316
Methodology: https://510kreport.com/methodology