510(k) · Cleared
ClearedPyeloscope System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richard Wolf Medical Instruments Corp. · FGA Kit, Nephroscope
Cleared on Apr 28, 1977 after an 8-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 13 devices in its family, counting itself, has a Class I recall. 12 later devices descend from it.
- Decided
- Apr 28, 1977
- Review
- 8 days
- Class
- Class II
- Product code
- FGA
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 1 citing it directly. 1 of the 13 devices in this family, counting this one, has a Class I recall.
- This deviceK770729 Pyeloscope SystemRichard Wolf Medical Instruments Corp. · 1977
- Descendant · cites it directly · 11 of its ownK994223 Nephroscope, 12 Degrees; Diaphragm Valve; Irrigation Attachment…Richard Wolf Medical Instruments Corp. · 2000
- Descendant · 2 generations on · 8 of its ownK151308 Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope SetSchoelly Fiberoptic GmbH · 2016
- Descendant · 3 generations on · 7 of its ownK161110 ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd. · 2016
- Descendant · 4 generations on · 1 of its ownK243820 Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s…Dornier Medtech America · 2025
- Descendant · 4 generations on · 0 of its ownK261915 Navigator™ Flex Ureteral Access Sheath SetBoston Scientific Corporation · 2026
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K200770 Mini PCNL-System2 generations on · 2021
Most influential descendants
Showing 5 of 12 · See all- K994223Nephroscope, 12 Degrees; Diaphragm Valve; Irrigation Attachment; Nephroscope, 20 Degree…Richard Wolf Medical Instruments Corp. · 2000 · cites it directly11descendants
- K151308Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope SetSchoelly Fiberoptic GmbH · 2016 · 2 generations on8descendants
- K161110ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd. · 2016 · 3 generations on7descendants
- K243820Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040…Dornier Medtech America · 2025 · 4 generations on1descendant
- K261915Navigator™ Flex Ureteral Access Sheath SetBoston Scientific Corporation · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K770729 | Pyeloscope System | Richard Wolf Medical Instruments Corp. | 1977 | — |
| +1 | K994223 | Nephroscope, 12 Degrees; Diaphragm Valve; Irrigation Attachment; Nephroscope… | Richard Wolf Medical Instruments Corp. | 2000 | — |
| +2 | K151308 | Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set | Schoelly Fiberoptic GmbH | 2016 | — |
| +3 | K161110 | ClearPetra Suction-Evacuation Sheath | Well Lead Medical Co., Ltd. | 2016 | — |
| +4 | K243820 | Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040… | Dornier Medtech America | 2025 | — |
| +4 | K261915 | Navigator™ Flex Ureteral Access Sheath Set | Boston Scientific Corporation | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2016 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 1 |
| 2022 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FGA device
- #1 K232370 Percutaneous Nephroscope Systemscore 5.3 · 1 generation · no Class I recall
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K994223 | Nephroscope, 12 Degrees; Diaphragm Valve; Irrigation Attachment; Nephroscope, 20 Degree… | 2000 | 11 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K200770Mini PCNL-SystemTrokamed GmbH · 2021 · 2 generations on · ◆ in the 2021 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
- Of its descendants, K994223 (Richard Wolf Medical Instruments Corp., 2000) has gone furthest, with 11 descendants of its own.
How does its category compare?
All FGA devicesFGA Kit, Nephroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FGA
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · FGA
Too few FGA 510(k)s in any year since 2007 to give a median.
Recalls per year · FGA
No recall names FGA since 2007.
Adverse event reports per year · FGA
36in 2025
MAUDE reports naming product code FGA, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 11 |
| 2024 | 1 | — | 0 | 23 |
| 2025 | 0 | — | 0 | 36 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K770729 · printed Nov 6, 2026
Cite this page
510(k) Report. “K770729: Pyeloscope System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K770729
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026