510(k) · Cleared
ClearedKarl Storz Ent Shaver
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · EQJ Bur, Ear, Nose And Throat
Cleared on Sep 6, 1995 after a 50-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it.
- Decided
- Sep 6, 1995
- Review
- 50 days
- Class
- Class I
- Product code
- EQJ
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 1 citing it directly.
- This deviceK953370 Karl Storz Ent ShaverKARL STORZ Endoscopy-America, Inc. · 1995
- Descendant · cites it directly · 9 of its ownK984521 Riwo Drive System 2302 with Generator, Small Motor Handles…Richard Wolf Medical Instruments Corp. · 1999
- Descendant · 2 generations on · 8 of its ownK030082 Power Control 2303 with Power Stick M4, Model# 2303.011/.901/.911…Richard Wolf Medical Instruments Corp. · 2003
- Descendant · 3 generations on · 6 of its ownK041610 Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207Richard Wolf Medical Instruments Corp. · 2004
- Descendant · 4 generations on · 2 of its ownK192499 Cyber BladeSIDAM S.r.l. · 2020
- Descendant · 4 generations on · 1 of its ownK213597 MultiCut SoloAsclepion Laser Technologies GmbH · 2023
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K984521Riwo Drive System 2302 with Generator, Small Motor Handles, 8563.111, 8563.351Richard Wolf Medical Instruments Corp. · 1999 · cites it directly9descendants
- K030082Power Control 2303 with Power Stick M4, Model# 2303.011/.901/.911, 8564.121/.851Richard Wolf Medical Instruments Corp. · 2003 · 2 generations on8descendants
- K041610Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207Richard Wolf Medical Instruments Corp. · 2004 · 3 generations on6descendants
- K192499Cyber BladeSIDAM S.r.l. · 2020 · 4 generations on2descendants
- K213597MultiCut SoloAsclepion Laser Technologies GmbH · 2023 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K953370 | Karl Storz Ent Shaver | KARL STORZ Endoscopy-America, Inc. | 1995 | — |
| +1 | K984521 | Riwo Drive System 2302 with Generator, Small Motor Handles, 8563.111, 8563.351 | Richard Wolf Medical Instruments Corp. | 1999 | — |
| +2 | K030082 | Power Control 2303 with Power Stick M4, Model# 2303.011/.901/.911, 8564.121/.851 | Richard Wolf Medical Instruments Corp. | 2003 | — |
| +3 | K041610 | Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207 | Richard Wolf Medical Instruments Corp. | 2004 | — |
| +4 | K192499 | Cyber Blade | SIDAM S.r.l. | 2020 | — |
| +4 | K213597 | MultiCut Solo | Asclepion Laser Technologies GmbH | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EQJ? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K984521 | Riwo Drive System 2302 with Generator, Small Motor Handles, 8563.111, 8563.351 | 1999 | 9 |
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?
- Of its descendants, K984521 (Richard Wolf Medical Instruments Corp., 1999) has gone furthest, with 9 descendants of its own.
How does its category compare?
All EQJ devicesEQJ Bur, Ear, Nose And Throat: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EQJ
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · EQJ
Too few EQJ 510(k)s in any year since 2007 to give a median.
Recalls per year · EQJ
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EQJ
435in 2025
MAUDE reports naming product code EQJ, 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 | 21 |
| 2008 | 0 | — | 0 | 21 |
| 2009 | 0 | — | 0 | 10 |
| 2010 | 0 | — | 0 | 30 |
| 2011 | 0 | — | 0 | 65 |
| 2012 | 0 | — | 0 | 84 |
| 2013 | 0 | — | 0 | 76 |
| 2014 | 0 | — | 0 | 95 |
| 2015 | 0 | — | 0 | 93 |
| 2016 | 0 | — | 0 | 95 |
| 2017 | 1 | — | 0 | 118 |
| 2018 | 0 | — | 0 | 204 |
| 2019 | 0 | — | 0 | 129 |
| 2020 | 0 | — | 0 | 100 |
| 2021 | 0 | — | 1 | 131 |
| 2022 | 0 | — | 0 | 229 |
| 2023 | 0 | — | 0 | 261 |
| 2024 | 0 | — | 0 | 368 |
| 2025 | 0 | — | 0 | 435 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K953370 · printed Nov 6, 2026
Cite this page
510(k) Report. “K953370: Karl Storz Ent Shaver.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K953370
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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