# K970971: Uro Med Nerve Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Uromed Corp.
- Decided: Oct 27, 1997 after 224 days
- Product code: ETN (Stimulator, Nerve)
- Device class: 2
- Regulation: 21 CFR 874.1820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K844216 (1985). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K844216: Grass Model NL Facial Nerve Locator & Monitor, Grass Instrument Co. (1985) Summary page 1.

## Cited in the summary but kept off the family tree
- K830221: Bedside N.P.T. 9900 - Printer 9800, Browne Medical, Inc. (1983). Our OCR of the scanned summary read K830221, FDA’s number for Bedside N.P.T. 9900 - Printer 9800 (Browne Medical, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Brown Nocturnal Penile Tumescence Monitor”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K993436: Cavermap Surgical Aid (2000), 1 descendant of its own
- K200886: StimSite (2020), 0 descendants of its own

## Indications for use
The Urovations Nerve Stimulator is indicated for use in the stimulation of the cavernosal nerves during open prostatectomy (surgical) procedures, aiding the surgeon in locating these nerves. The device is designed as an adjunct to current open prostatectomy procedures in which a nerve sparing technique is used. The Nerve Stimulator is not designed to replace the surgeon’s expertise in mapping out the vascular bundles. Each surgeon’s skill determines whether these nerves are spared regardless of any aid.

Source page: https://510kreport.com/device/K970971
Methodology: https://510kreport.com/methodology