# K032981: Sppro Esp, Models Esp 603-18-05, Esp 603-18-09

- Pathway: 510(k) (Traditional)
- Applicant: Invamed Technologies, Inc.
- Decided: Apr 22, 2004 after 211 days
- Product code: BSP (Needle, Conduction, Anesthetic (W/Wo Introducer))
- Device class: 2
- Regulation: 21 CFR 868.5150
- 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 K813179 (1981). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980536: Epidural Needle, Manan Medical Products, Inc. (1998) Summary page 2.
- K983620: Manan Spinal Needles, Manan Medical Products, Inc. (1999) Summary page 2.
- K013610: Perifix Safety Epidural Needles, B.Braun Medical, Inc. (2002) Summary page 2.

## Indications for use
The SPproTM ESP is an anesthesia conduction needle incorporating a needle tip shielding mechanism to aid in the prevention of needle-stick injuries after use to deliver an anesthetic and/or therapeutic agent to provide regional anesthesia. The needle can be used for a single dose administration or in conjunction with a catheter for continuous regional anesthesia.

Source page: https://510kreport.com/device/K032981
Methodology: https://510kreport.com/methodology