510(k) · Cleared
ClearedSchoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Schoelly Fiberoptic GmbH · FGA Kit, Nephroscope
Cleared on Feb 9, 2016 as substantially equivalent to K994223 (Richard Wolf Medical Instruments Corp., 2000) after a 267-day review. Its family tree reaches back 2 generations to 1977. 8 later devices descend from it.
- Decided
- Feb 9, 2016
- Review
- 267 days
- Class
- Class II
- Product code
- FGA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K770729 (1977). 8 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK770729 Pyeloscope SystemRichard Wolf Medical Instruments Corp. · 1977
- 1 generation backK994223 Nephroscope, 12 Degrees; Diaphragm Valve; Irrigation Attachment…Richard Wolf Medical Instruments Corp. · 2000
- This deviceK151308 Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope SetSchoelly Fiberoptic GmbH · 2016
- Descendant · cites it directly · 7 of its ownK161110 ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd. · 2016
- Descendant · 2 generations on · 1 of its ownK243820 Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s…Dornier Medtech America · 2025
- Descendant · 2 generations on · 0 of its ownK261915 Navigator™ Flex Ureteral Access Sheath SetBoston Scientific Corporation · 2026
- Descendant · 3 generations on · 0 of its ownK252572 Prodeon Urethral Sheath SystemProdeon Medical, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK250128 Single Use Suction-Evacuation Ureteral Access SheathAnhui Happiness Workshop Medical Instruments Co., Ltd. · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K161110ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd. · 2016 · cites it directly7descendants
- K243820Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040…Dornier Medtech America · 2025 · 2 generations on1descendant
- K261915Navigator™ Flex Ureteral Access Sheath SetBoston Scientific Corporation · 2026 · 2 generations on0descendants
- K252572Prodeon Urethral Sheath SystemProdeon Medical, Inc. · 2025 · 3 generations on0descendants
- K250128Single Use Suction-Evacuation Ureteral Access SheathAnhui Happiness Workshop Medical Instruments Co., Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K151308 | Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set | Schoelly Fiberoptic GmbH | 2016 | — |
| +1 | K161110 | ClearPetra Suction-Evacuation Sheath | Well Lead Medical Co., Ltd. | 2016 | — |
| +2 | K243820 | Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040… | Dornier Medtech America | 2025 | — |
| +2 | K261915 | Navigator™ Flex Ureteral Access Sheath Set | Boston Scientific Corporation | 2026 | — |
| +3 | K252572 | Prodeon Urethral Sheath System | Prodeon Medical, Inc. | 2025 | — |
| +2 | K250128 | Single Use Suction-Evacuation Ureteral Access Sheath | Anhui Happiness Workshop Medical Instruments Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2020 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 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 FGA? 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? (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 |
|---|---|---|---|
| * | K994223 | Nephroscope, 12 Degrees; Diaphragm Valve; Irrigation Attachment; Nephroscope, 20 Degree…Summary page 4…21 CFR 876.1500; Class II FFL - Ureteral stone dislodger 21 CFR 876.4680; Class II Premarket Notification: K994223, Richard Wolf Medical Instruments Corp., SE date June 5, 2000 Recalls: This pred… | 2000 |
| † | K963855 | 12 Ureteroscopes/Uretero-Renoscopes | 1997 |
| † | K940594 | Karl Storz Adult & Pediatric Nephroscope | 1994 |
| † | K072521 | Cook Fiber Optic Bundle and Flexor Deflecting Access Sheath | 2007 |
| † | K142249 | Schoelly Sinuscope | 2015 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161110 | ClearPetra Suction-Evacuation Sheath | 2016 | 7 |
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 39 years and passes through 2 companies; a new generation was cleared every 23.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K161110 (Well Lead Medical Co., Ltd., 2016) has gone furthest, with 7 descendants of its own.
- 2 other devices also cite its predicate K994223.
How does its category compare?
All FGA devicesFGA Kit, Nephroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The Schoelly Nephroscope Set is used for the disintegration and removal / extraction of kidney stones. The stones are removed, under endoscopic control, through percutaneous passages, in conjunction with intracorporeal pneumatic, ultrasound, electrohydraulic or laser lithotripters.
The Schoelly Ultra-Mini Nephroscope Set is used for the disintegration and removal / extraction of kidney stones. The stones are removed, under endoscopic control, through percutaneous passages, in conjunction with laser lithotripters.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151308 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151308: Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151308
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