510(k) · Cleared
ClearedKsea Unidrive Ent/Neuro/Omfs System and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Cleared on Dec 19, 2005 after a 27-day review. The FDA summary names no predicate by number. 2 later devices descend from it.
- Decided
- Dec 19, 2005
- Review
- 27 days
- Class
- Class II
- Product code
- ERL
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK053262 Ksea Unidrive Ent/Neuro/Omfs System and AccessoriesKARL STORZ Endoscopy-America, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK150969 Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II…Karl Storz Endoscopy America, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK200318 UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X…KARL STORZ Endoscopy-America, Inc. · 2020
Most influential descendants
Showing 2 of 2 · See all- K150969Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High…Karl Storz Endoscopy America, Inc. · 2016 · cites it directly1descendant
- K200318UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver HandpieceKARL STORZ Endoscopy-America, Inc. · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K053262 | Ksea Unidrive Ent/Neuro/Omfs System and Accessories | KARL STORZ Endoscopy-America, Inc. | 2005 | — |
| +1 | K150969 | Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver… | Karl Storz Endoscopy America, Inc. | 2016 | — |
| +2 | K200318 | UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N… | KARL STORZ Endoscopy-America, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2020 | 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 ERL? 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 ERL device
- #1 K243280 Piezomed Pro (Piezomed Pro module M-PM100…score 12.0 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150969 | Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High… | 2016 | 1 |
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, K150969 (Karl Storz Endoscopy America, Inc., 2016) has gone furthest, with 1 descendant of its own.
How does its category compare?
All ERL devicesERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ERL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ERL
191in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ERL
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ERL
1,469in 2025
MAUDE reports naming product code ERL, 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 | 112 |
| 2008 | 6 | 181 | 0 | 60 |
| 2009 | 1 | — | 1 | 249 |
| 2010 | 0 | — | 0 | 444 |
| 2011 | 0 | — | 0 | 1,068 |
| 2012 | 2 | — | 0 | 1,379 |
| 2013 | 2 | — | 3 | 3,231 |
| 2014 | 1 | — | 0 | 1,975 |
| 2015 | 3 | 86 | 0 | 2,630 |
| 2016 | 4 | 180 | 0 | 1,455 |
| 2017 | 2 | — | 0 | 999 |
| 2018 | 1 | — | 0 | 1,380 |
| 2019 | 1 | — | 0 | 2,515 |
| 2020 | 1 | — | 5 | 2,369 |
| 2021 | 1 | — | 1 | 2,283 |
| 2022 | 3 | 191 | 0 | 1,574 |
| 2023 | 0 | — | 0 | 1,725 |
| 2024 | 1 | — | 0 | 1,588 |
| 2025 | 1 | — | 0 | 1,469 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The STAMMBERGER Paranasal Shaver 9 0 Handpiece, the straight Micro-Shaver Handpiece, or the STAMMBERGER-CASTELNUOVO DrillCut-X Shaver Handpiece in conjunction with the UNIDRIVE ENT control unit is a motorized, reusable surgical device system, intended for use by qualified surgeons to shave, debride or cut tissue during Head, Neck, ENT and Otoneurological surgical procedures. The KSEA Stammberger-Sachse Intranasal Drill or ENT Drill in conjunction with…
Read the full statement (99 words)
The STAMMBERGER Paranasal Shaver 9 0 Handpiece, the straight Micro-Shaver Handpiece, or the STAMMBERGER-CASTELNUOVO DrillCut-X Shaver Handpiece in conjunction with the UNIDRIVE ENT control unit is a motorized, reusable surgical device system, intended for use by qualified surgeons to shave, debride or cut tissue during Head, Neck, ENT and Otoneurological surgical procedures.
The KSEA Stammberger-Sachse Intranasal Drill or ENT Drill in conjunction with the UNIDRIVE ENT control unit is a motorized, reusable surgical device system, intended for use by qualified surgeons to provide controlled cutting, drilling, sawing and removal of bone during Head, Neck, ENT and Otoneurological surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053262 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053262: Ksea Unidrive Ent/Neuro/Omfs System and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053262
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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