510(k) · Cleared
ClearedMorce Scope Set 8970 with Power Control 2303 and Suction Pump 2207
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richard Wolf Medical Instruments Corp. · FJL Resectoscope
Cleared on Aug 19, 2004 as substantially equivalent to K970105 (Richard Wolf Medical Instruments Corp., 1997) and 1 other predicate after a 65-day review. Its family tree reaches back 4 generations to 1987. 6 later devices descend from it.
- Decided
- Aug 19, 2004
- Review
- 65 days
- Class
- Class II
- Product code
- FJL
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K871250 (1987). 10 ancestors in all. 6 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK871250 Intra-Articulated Arthro Power SystemRichard Wolf Medical Instruments Corp. · 1987
- 3 generations backK970088 Riwo Drive with Footswitch/Motor Handle…Richard Wolf Medical Instruments Corp. · 1997
- 2 generations backK984521 Riwo Drive System 2302 with Generator, Small Motor Handles…Richard Wolf Medical Instruments Corp. · 1999
- 1 generation backK030082 Power Control 2303 with Power Stick M4, Model# 2303.011/.901/.911…Richard Wolf Medical Instruments Corp. · 2003
- This deviceK041610 Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207Richard Wolf Medical Instruments Corp. · 2004
- Descendant · cites it directly · 2 of its ownK192499 Cyber BladeSIDAM S.r.l. · 2020
- Descendant · cites it directly · 1 of its ownK213597 MultiCut SoloAsclepion Laser Technologies GmbH · 2023
- Descendant · 2 generations on · 0 of its ownK260884 UNIDRIVE Select SystemKarl Storz SE & CO. KG · 2026
- Descendant · 2 generations on · 0 of its ownK251923 Medical Shaver System (Morcellator) (YSB-IIIA)Hangzhou Hawk Optical Electronic Instruments Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK240831 MultiCut SoloAsclepion Laser Technologies GmbH · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K192499Cyber BladeSIDAM S.r.l. · 2020 · cites it directly2descendants
- K213597MultiCut SoloAsclepion Laser Technologies GmbH · 2023 · cites it directly1descendant
- K260884UNIDRIVE Select SystemKarl Storz SE & CO. KG · 2026 · 2 generations on0descendants
- K251923Medical Shaver System (Morcellator) (YSB-IIIA)Hangzhou Hawk Optical Electronic Instruments Co., Ltd. · 2026 · 2 generations on0descendants
- K240831MultiCut SoloAsclepion Laser Technologies GmbH · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K871250 | Intra-Articulated Arthro Power System | Richard Wolf Medical Instruments Corp. | 1987 | — |
| −3 | K970088 | Riwo Drive with Footswitch/Motor Handle, Coomplete,6000RPM/3000RPM/Rotary… | Richard Wolf Medical Instruments Corp. | 1997 | — |
| −2 | K984521 | Riwo Drive System 2302 with Generator, Small Motor Handles, 8563.111, 8563.351 | Richard Wolf Medical Instruments Corp. | 1999 | — |
| −1 | K030082 | Power Control 2303 with Power Stick M4, Model# 2303.011/.901/.911, 8564.121/.851 | Richard Wolf Medical Instruments Corp. | 2003 | — |
| 0 (this device) | K041610 | Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207 | Richard Wolf Medical Instruments Corp. | 2004 | — |
| +1 | K192499 | Cyber Blade | SIDAM S.r.l. | 2020 | — |
| +1 | K213597 | MultiCut Solo | Asclepion Laser Technologies GmbH | 2023 | — |
| +2 | K260884 | UNIDRIVE Select System | Karl Storz SE & CO. KG | 2026 | — |
| +2 | K251923 | Medical Shaver System (Morcellator) (YSB-IIIA) | Hangzhou Hawk Optical Electronic Instruments Co., Ltd. | 2026 | — |
| +2 | K240831 | MultiCut Solo | Asclepion Laser Technologies GmbH | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 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 FJL? 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 FJL device
- #1 K221893 KARL STORZ Bipolar Resectoscopes with HF Cablescore 7.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K970105 | Riwo Cut-Morcellator Existing of Knife/Cutting Sleeve/Protection Sleeve/Claw Grasping…Summary page 1…ces to which substantial equivalence is claimed 510(k) ~~Trade or proprietary or model name Manufacturer Number 1 ~K9701 05 I RIWO CUT Morcellator 1 Richard Wolf 2 K~030082 2 Power Control 2303 with Power… | 1997 |
| * | K030082 | Power Control 2303 with Power Stick M4, Model# 2303.011/.901/.911, 8564.121/.851Summary page 1…oprietary or model name Manufacturer Number 1 ~K9701 05 I RIWO CUT Morcellator 1 Richard Wolf 2 K~030082 2 Power Control 2303 with Power Stick M4 2 Richard Wolf 3 K1111 3 Suction Pump for Intracorporeal U… | 2003 |
| Kept off the family tree | K911911 | FDA’s K911911 is Medical Designs, Inc. Bio-Therapy System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1992 |
| Kept off the family tree | K098515 | Model #688PD4 Drive Power Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 17 years and passes through 1 company; a new generation was cleared every 4.6 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K192499 (SIDAM S.r.l., 2020) has gone furthest, with 2 descendants of its own.
How does its category compare?
All FJL devicesFJL Resectoscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FJL
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · FJL
Too few FJL 510(k)s in any year since 2007 to give a median.
Recalls per year · FJL
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FJL
67in 2025
MAUDE reports naming product code FJL, 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 | 11 |
| 2008 | 0 | — | 0 | 11 |
| 2009 | 0 | — | 0 | 15 |
| 2010 | 1 | — | 0 | 34 |
| 2011 | 0 | — | 0 | 18 |
| 2012 | 0 | — | 0 | 26 |
| 2013 | 0 | — | 1 | 24 |
| 2014 | 0 | — | 0 | 36 |
| 2015 | 0 | — | 0 | 45 |
| 2016 | 0 | — | 0 | 25 |
| 2017 | 1 | — | 0 | 28 |
| 2018 | 0 | — | 0 | 50 |
| 2019 | 2 | — | 0 | 53 |
| 2020 | 0 | — | 0 | 55 |
| 2021 | 0 | — | 0 | 54 |
| 2022 | 0 | — | 1 | 74 |
| 2023 | 2 | — | 0 | 74 |
| 2024 | 1 | — | 0 | 34 |
| 2025 | 0 | — | 0 | 67 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Morce Scope Set 8970: The Morce Scope Set, in conjunction with a morcellation probe, and with its sheaths and obturators, is used in the cutting (morcellation) and continuous removal of large detached tissue masses. In combination with intracorporeal lithotriptors, e.g. operated pneumatically, by ultrasound, electro-hydraulically or by laser under endoscopic control, it can be used as a nephroscope in the disintegration and removal/aspiration of kidney…
Read the full statement (186 words)
Morce Scope Set 8970:
The Morce Scope Set, in conjunction with a morcellation probe, and with its sheaths and obturators, is used in the cutting (morcellation) and continuous removal of large detached tissue masses.
In combination with intracorporeal lithotriptors, e.g. operated pneumatically, by ultrasound, electro-hydraulically or by laser under endoscopic control, it can be used as a nephroscope in the disintegration and removal/aspiration of kidney and bladder stones and the removal of detached tumors from the bladder.
Power Control 2303:
The POWER CONTROL 2303 in conjunction with POWER STICK M4 serves to drive WOLF morcellators for the continuous removal of ablated tissue in endoscopic operations.
Suction Pump 2207:
The SUCTION PUMP is used for aspirating irrigation fluid in conjunction with a resectoscope or a morcellator following laser TURP.
When used as a Morce Scope: for therapy via the transurethral passage after a TURP (TransUrethral Resection of the Prostate) procedure.
When used as a nephroscope: for diagnosis and therapy of urolithiasis.
In both cases the product must be used in conjunction with endoscopic accessories. The product may only be applied by adequately qualified and trained medical personnel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041610 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041610: Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041610
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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