510(k) · Cleared
ClearedRiwo Drive System 2302 with Generator, Small Motor Handles, 8563.111, 8563.351
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richard Wolf Medical Instruments Corp. · EQL Laryngostroboscope
Cleared on Mar 17, 1999 as substantially equivalent to K970088 (Richard Wolf Medical Instruments Corp., 1997) and 3 other predicates after an 86-day review. Its family tree reaches back 2 generations to 1987. 9 later devices descend from it.
- Decided
- Mar 17, 1999
- Review
- 86 days
- Class
- Class I
- Product code
- EQL
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K871250 (1987). 5 ancestors in all. 9 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK871250 Intra-Articulated Arthro Power SystemRichard Wolf Medical Instruments Corp. · 1987
- 1 generation backK970088 Riwo Drive with Footswitch/Motor Handle…Richard Wolf Medical Instruments Corp. · 1997
- This deviceK984521 Riwo Drive System 2302 with Generator, Small Motor Handles…Richard Wolf Medical Instruments Corp. · 1999
- Descendant · cites it directly · 8 of its ownK030082 Power Control 2303 with Power Stick M4, Model# 2303.011/.901/.911…Richard Wolf Medical Instruments Corp. · 2003
- Descendant · 2 generations on · 6 of its ownK041610 Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207Richard Wolf Medical Instruments Corp. · 2004
- Descendant · 3 generations on · 2 of its ownK192499 Cyber BladeSIDAM S.r.l. · 2020
- Descendant · 3 generations on · 1 of its ownK213597 MultiCut SoloAsclepion Laser Technologies GmbH · 2023
- Descendant · 4 generations on · 0 of its ownK260884 UNIDRIVE Select SystemKarl Storz SE & CO. KG · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K030082Power Control 2303 with Power Stick M4, Model# 2303.011/.901/.911, 8564.121/.851Richard Wolf Medical Instruments Corp. · 2003 · cites it directly8descendants
- K041610Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207Richard Wolf Medical Instruments Corp. · 2004 · 2 generations on6descendants
- K192499Cyber BladeSIDAM S.r.l. · 2020 · 3 generations on2descendants
- K213597MultiCut SoloAsclepion Laser Technologies GmbH · 2023 · 3 generations on1descendant
- K260884UNIDRIVE Select SystemKarl Storz SE & CO. KG · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K871250 | Intra-Articulated Arthro Power System | Richard Wolf Medical Instruments Corp. | 1987 | — |
| −1 | K970088 | Riwo Drive with Footswitch/Motor Handle, Coomplete,6000RPM/3000RPM/Rotary… | Richard Wolf Medical Instruments Corp. | 1997 | — |
| 0 (this device) | 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 | — |
| +2 | K041610 | Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207 | Richard Wolf Medical Instruments Corp. | 2004 | — |
| +3 | K192499 | Cyber Blade | SIDAM S.r.l. | 2020 | — |
| +3 | K213597 | MultiCut Solo | Asclepion Laser Technologies GmbH | 2023 | — |
| +4 | K260884 | UNIDRIVE Select System | Karl Storz SE & CO. KG | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 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 EQL? 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K970088 | Riwo Drive with Footswitch/Motor Handle, Coomplete,6000RPM/3000RPM/Rotary Blades and…Summary page 1…ion name: ) Drive Generator, Motor Handles ENT electric surgical drill Information on devices to whic 510(k) Number Trade or proprietary or model name _ Manufacturer 1 K970088 1 RIWO Drive Generator with Footswitch, Motor 1 Richard Wolf handles and single use rotary blades and abraders 2 K972584 2 Hummer… | 1997 |
| * | K972584 | Stryker Hummer II Microdebrider SystemSummary page 1…de or proprietary or model name _ Manufacturer 1 K970088 1 RIWO Drive Generator with Footswitch, Motor 1 Richard Wolf handles and single use rotary blades and abraders 2 K972584 2 Hummer ENT micro debrdier 2 Stryker 3 K973499 3 XPS Straightshot Microresector 3 Xomed 4 K953370 4 Karl Storz Paranasal Sinus S… | 1997 |
| * | K973499 | XPS Straightshot Microbrider System or Trebay Shaver SystemSummary page 1…K970088 1 RIWO Drive Generator with Footswitch, Motor 1 Richard Wolf handles and single use rotary blades and abraders 2 K972584 2 Hummer ENT micro debrdier 2 Stryker 3 K973499 3 XPS Straightshot Microresector 3 Xomed 4 K953370 4 Karl Storz Paranasal Sinus Shaver 4 Karl Storz 1.0 Description The RIWO Dr… | 1998 |
| * | K953370 | Karl Storz Ent ShaverSummary page 1…tor 1 Richard Wolf handles and single use rotary blades and abraders 2 K972584 2 Hummer ENT micro debrdier 2 Stryker 3 K973499 3 XPS Straightshot Microresector 3 Xomed 4 K953370 4 Karl Storz Paranasal Sinus Shaver 4 Karl Storz 1.0 Description The RIWO Drive Generator is designed to efficiently drive and… | 1995 |
What descends from it? (9)
2 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 12 years and passes through 1 company; a new generation was cleared every 9.9 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K030082 (Richard Wolf Medical Instruments Corp., 2003) has gone furthest, with 8 descendants of its own.
- 3 other devices also cite its predicate K970088.
How does its category compare?
All EQL devicesEQL Laryngostroboscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EQL
FDA has decided no EQL device since 2007.
Median 510(k) review, days · EQL
Too few EQL 510(k)s in any year since 2007 to give a median.
Recalls per year · EQL
No recall names EQL since 2007.
Adverse event reports per year · EQL
28in 2025
MAUDE reports naming product code EQL, 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 | 0 | — | 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 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 5 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 32 |
| 2023 | 0 | — | 0 | 25 |
| 2024 | 0 | — | 0 | 39 |
| 2025 | 0 | — | 0 | 28 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The RIWO Drive with small motor handle is used for driving Wolf rotary blades and abraders for the removal of pathological tissue during endoscopic interventions. Simultaneous suction (evacuation) allows continuous removal of ablated tissue, with motor handle 8563.311 additionally supported by irrigation. For therapy with endoscopic accessories: • in arthroscopy, e.g. for meniscus resection, removal of soft tissue, as well as intra-articular severing or…
Read the full statement (113 words)
The RIWO Drive with small motor handle is used for driving Wolf rotary blades and abraders for the removal of pathological tissue during endoscopic interventions.
Simultaneous suction (evacuation) allows continuous removal of ablated tissue, with motor handle 8563.311 additionally supported by irrigation.
For therapy with endoscopic accessories:
• in arthroscopy, e.g. for meniscus resection, removal of soft tissue, as well as intra-articular severing or abrasion of osseous tissue, e.g. ACL or shoulder procedures.
• thoracic surgery, e.g. for removing hematomas
• sinus surgery (ENT), e.g. for removing polyps or cysts. In certain cases, bone structures are removed or trimmed.
• spine surgery (arthroscopic micro disectomy (AMD), spinal endendoscopsy) e.g. removal of pathological tissue.
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/K984521 · printed Nov 5, 2026
Cite this page
510(k) Report. “K984521: Riwo Drive System 2302 with Generator, Small Motor Handles, 8563.111, 8563.351.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K984521
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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