510(k) · Cleared
ClearedDirectvision Guide System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Percuvision, LLC · FGC Urethroscope
Cleared on Aug 25, 2009 as substantially equivalent to K020310 (Davlite Technologies, 2002) after an 83-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Aug 25, 2009
- Review
- 83 days
- Class
- Class II
- Product code
- FGC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K932987 (1994). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K932987 | Birtcher Laparoscope and Accessories | Birtcher Medical Systems, Inc. | 1994 | — |
| −1 | K020310 | Davlite Microendoscope & Accessories | Davlite Technologies | 2002 | — |
| 0 (this device) | K091600 | Directvision Guide System | Percuvision, LLC | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 FGC? 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 |
|---|---|---|---|
| * | K020310 | Davlite Microendoscope & Accessories | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 7.9 years on median.
- None of the 3 ancestors has a recall.
- 4 other devices also cite its predicate K020310.
How does its category compare?
All FGC devicesFGC Urethroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · FGC
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · FGC
Too few FGC 510(k)s in any year since 2007 to give a median.
Recalls per year · FGC
No recall names FGC since 2007.
Adverse event reports per year · FGC
555in 2025
MAUDE reports naming product code FGC, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 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 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 33 |
| 2023 | 0 | — | 0 | 346 |
| 2024 | 0 | — | 0 | 455 |
| 2025 | 0 | — | 0 | 555 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The DirectVision TM Guide System is indicated for use in the visual examination of the urethra and bladder when placing the PercuCath Urologic Catheter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091600 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091600: Directvision Guide System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091600
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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