# K031527: Modification to Cavermap Surgical Aid

- Pathway: 510(k) (Special)
- Applicant: Blue Torch Medical Technologies
- Decided: Jun 5, 2003 after 21 days
- Product code: FGM (Probe And Director, Gastro-Urology)
- Device class: 1
- Regulation: 21 CFR 876.4730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K970971: Uro Med Nerve Stimulator, Uromed Corp. (1997). Our reading of the summary gave K970971, FDA’s number for Uro Med Nerve Stimulator (Uromed Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Blue Torch Medical Technologies CaverMap Surgical Aid”. Kept off the family tree. Summary page 1.

## Indications for use
The Blue Torch Medical Technologies CaverMapB Surgical Aid Video Monitor is a modification to the Blue Torch Medical Technologies CaverMapR Surgical Aid System. The system is indicated for use in the stimulation of the cavernosal and associated parasympathetic nerves during open or laproscopic prostatectomy and open colorectal (surgical) procedures in males. The device aids the surgeon in locating these nerves. The device is designed as an adjunct to the current open or laproscopic prostatectomy and open colorectal procedures in which a nerve sparing technique is used. The Surgical Aid is not designed to replace the surgeon’s expertise in mapping out the neurovascular bundles. Each surgeon’s skill determines whether these nerves are spared regardless of any aid.

Source page: https://510kreport.com/device/K031527
Methodology: https://510kreport.com/methodology