510(k) · Cleared
ClearedDiego Powered Dissector and Drill System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gyrus Ent LLC · ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Cleared on Mar 8, 2002 after a 14-day review. The FDA summary names its predicate without a number. 61 later devices descend from it.
- Decided
- Mar 8, 2002
- Review
- 14 days
- Class
- Class II
- Product code
- ERL
- Recalls
- None
- Predicates
- 0
61 later devices descend from it, 5 citing it directly.
- This deviceK020594 Diego Powered Dissector and Drill SystemGyrus Ent LLC · 2002
- Descendant · cites it directly · 50 of its ownK034004 Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC · 2004
- Descendant · 2 generations on · 44 of its ownK072302 Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008
- Descendant · 3 generations on · 42 of its ownK081542 Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008
- Descendant · 4 generations on · 41 of its ownK093007 Entellus Medical Balloon DeviceEntellus Medical, Inc. · 2010
- Descendant · 4 generations on · 36 of its ownK102003 Xpress Balloon DeviceEntellus Medical, Inc. · 2010
Showing 5 of 61 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 61 · See all- K034004Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC · 2004 · cites it directly50descendants
- K072302Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008 · 2 generations on44descendants
- K081542Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008 · 3 generations on42descendants
- K093007Entellus Medical Balloon DeviceEntellus Medical, Inc. · 2010 · 4 generations on41descendants
- K102003Xpress Balloon DeviceEntellus Medical, Inc. · 2010 · 4 generations on36descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K020594 | Diego Powered Dissector and Drill System | Gyrus Ent LLC | 2002 | — |
| +1 | K034004 | Diego RF Powered Dissector and Drill System Console | Gyrus Ent LLC | 2004 | — |
| +2 | K072302 | Entellus Medical RS-Series System | Entellus Medical, Inc. | 2008 | — |
| +3 | K081542 | Modification to Entellus Medical RS-Series System | Entellus Medical, Inc. | 2008 | — |
| +4 | K093007 | Entellus Medical Balloon Device | Entellus Medical, Inc. | 2010 | — |
| +4 | K102003 | Xpress Balloon Device | Entellus Medical, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 5 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 7 | 0 |
| 2013 | 6 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 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 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? (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 |
|---|---|---|---|
| * | — | Turbo 7000 System Named without a submission number |
What descends from it? (61)
See all 615 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K034004 | Diego RF Powered Dissector and Drill System Console | 2004 | 50 |
| K083720 | Osseoduo, Shaver Handpiece S80 and S120, Micromotor 80K | 2009 | 5 |
| K030343 | Diego Powered Dissector Handpiece with Starlink Image-Guided Adapter Mounting Interface | 2003 | 3 |
| K142022 | Medline Renewal Reprocessed Gyrus-Diego Sinus Application Blades | 2014 | 0 |
| K073633 | Stryker Essx Microdebrider System | 2008 | 0 |
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, K034004 (Gyrus Ent LLC, 2004) has gone furthest, with 50 descendants 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 Diego Powered Dissector and Drill System’s intended use is the cutting and removal of bone and tissue in general ENT, Head & Neck, and otoneurologic procedures. Sinus applications would embody: ethmoidectomy/sphenoethmoidectomy polypectomy septoplasty and procedures such as antrostomy endoscopic DCR frontal sinus drill-out frontal sinus trephination and irrigation septal spurs removal trans-spehnoidal procedures Nasopharyngeal/laryngeal procedures…
Read the full statement (112 words)
The Diego Powered Dissector and Drill System’s intended use is the cutting and removal of bone and tissue in general ENT, Head & Neck, and otoneurologic procedures.
Sinus applications would embody:
ethmoidectomy/sphenoethmoidectomy
polypectomy
septoplasty and
procedures such as
antrostomy
endoscopic DCR
frontal sinus drill-out
frontal sinus trephination and irrigation
septal spurs removal
trans-spehnoidal procedures
Nasopharyngeal/laryngeal procedures would comprise:
adenoidectomy
laryngeal lesion de-bulking
laryngeal polypectomy
tracheal procedures
tonsillectomy
Head & Neck procedures would encompass:
soft tissue shaving
rhinoplasty (narrowing of the bony vault and revision of the bony pyramid)
removal of fatty (adipose) tissue (lipodebridement) in the maxillary and mandibular regions of the face
acoustic neuroma removal
Otology procedures would include:
mastoidectomy
mastoidotomy.
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/K020594 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020594: Diego Powered Dissector and Drill System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020594
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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