510(k) · Cleared
Recalled · 2003Cavermap Surgical Aid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Uromed Corp. · FGM Probe And Director, Gastro-Urology
Cleared on Feb 11, 2000 as substantially equivalent to K970971 (Uromed Corp., 1997) after a 122-day review. Its family tree reaches back 2 generations to 1985. 1 later device descends from it. It has been recalled once.
- Decided
- Feb 11, 2000
- Review
- 122 days
- Class
- Class I
- Product code
- FGM
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K844216 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK844216 Grass Model NL Facial Nerve Locator & MonitorGrass Instrument Co. · 1985
- 1 generation backK970971 Uro Med Nerve StimulatorUromed Corp. · 1997
- This deviceK993436 Cavermap Surgical AidUromed Corp. · 2000
- Descendant · cites it directly · 0 of its ownK200886 StimSiteAllotrope Medical, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K200886StimSiteAllotrope Medical, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K844216 | Grass Model NL Facial Nerve Locator & Monitor | Grass Instrument Co. | 1985 | — |
| −1 | K970971 | Uro Med Nerve Stimulator | Uromed Corp. | 1997 | — |
| 0 (this device) | K993436 | Cavermap Surgical Aid | Uromed Corp. | 2000 | — |
| +1 | K200886 | StimSite | Allotrope Medical, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FGM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K970971 | Uro Med Nerve StimulatorSummary page 1…21 CFR § 874.1820 Stmulator, Nerve 21 CFR § 876.4730 Probe And Director, Gastro-Urology Predicate Devices used for Substantial Equivalence UroMed CaverMap Surgical Aid K970971 Intended Use The UroMed CaverMap Surgical Aid is currently intended to provide stimulation to the body to locate and identify n… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200886 | StimSite | 2020 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 10, 2003 | Not classified | Z-1235-03 | Other | Product's sterility is compromised due to a failed sterility audit |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 12.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K200886 (Allotrope Medical, Inc., 2020) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FGM devicesFGM Probe And Director, Gastro-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FGM
FDA has decided no FGM device since 2007.
Median 510(k) review, days · FGM
Too few FGM 510(k)s in any year since 2007 to give a median.
Recalls per year · FGM
No recall names FGM since 2007.
Adverse event reports per year · FGM
1in 2015
MAUDE reports naming product code FGM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The UroMed CaverMap® Surgical Aid is indicated for use in the stimulation of the cavernosal and associated parasympathetic nerves during open prostatectomy and 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 prostatectomy and 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993436 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993436: Cavermap Surgical Aid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993436
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026