510(k) · Cleared
ClearedDiego RF Powered Dissector and Drill System Console
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 3, 2004 as substantially equivalent to K020594 (Gyrus Ent LLC, 2002) and 6 other predicates after a 70-day review. Its family tree reaches back 9 generations to 1994. 50 later devices descend from it.
- Decided
- Mar 3, 2004
- Review
- 70 days
- Class
- Class II
- Product code
- ERL
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 9 generations to K936109 (1994). 71 ancestors in all, the oldest K800617 (1980). 50 later devices descend from it, 6 citing it directly.
- Root · 9 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 5 generations between
- 3 generations backK014290 Entec Plasma WandsArthrocare Corp. · 2002
- 2 generations backK021364 Modification to Entec Plasma WandsArthrocare Corp. · 2002
- 1 generation backK030108 Arthrocare Ent Coblator Surgery SystemArthrocare Corp. · 2003 · Recalled
- This deviceK034004 Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC · 2004
- Descendant · cites it directly · 44 of its ownK072302 Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008
- Descendant · 2 generations on · 42 of its ownK081542 Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008
- Descendant · 3 generations on · 41 of its ownK093007 Entellus Medical Balloon DeviceEntellus Medical, Inc. · 2010
- Descendant · 3 generations on · 36 of its ownK102003 Xpress Balloon DeviceEntellus Medical, Inc. · 2010
- Descendant · 4 generations on · 21 of its ownK112506 Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2011
Show all 9 generations
- Root · 9 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 8 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 7 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 6 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 5 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 4 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 3 generations backK014290 Entec Plasma WandsArthrocare Corp. · 2002
- 2 generations backK021364 Modification to Entec Plasma WandsArthrocare Corp. · 2002
- 1 generation backK030108 Arthrocare Ent Coblator Surgery SystemArthrocare Corp. · 2003 · Recalled
- This deviceK034004 Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC · 2004
Showing 5 of 50 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 50 · See all- K072302Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008 · cites it directly44descendants
- K081542Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008 · 2 generations on42descendants
- K093007Entellus Medical Balloon DeviceEntellus Medical, Inc. · 2010 · 3 generations on41descendants
- K102003Xpress Balloon DeviceEntellus Medical, Inc. · 2010 · 3 generations on36descendants
- K112506Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc. · 2011 · 4 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −8 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −7 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −6 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −5 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −4 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| −3 | K014290 | Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −2 | K021364 | Modification to Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −1 | K030108 | Arthrocare Ent Coblator Surgery System | Arthrocare Corp. | 2003 | 1 |
| 0 (this device) | K034004 | Diego RF Powered Dissector and Drill System Console | Gyrus Ent LLC | 2004 | — |
| +1 | K072302 | Entellus Medical RS-Series System | Entellus Medical, Inc. | 2008 | — |
| +2 | K081542 | Modification to Entellus Medical RS-Series System | Entellus Medical, Inc. | 2008 | — |
| +3 | K093007 | Entellus Medical Balloon Device | Entellus Medical, Inc. | 2010 | — |
| +3 | K102003 | Xpress Balloon Device | Entellus Medical, Inc. | 2010 | — |
| +4 | K112506 | Xpress Multi-Sinus Dilation Tool | Entellus Medical, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 7 | 0 |
| 1996 | 8 | 0 |
| 1997 | 4 | 0 |
| 1998 | 6 | 0 |
| 1999 | 1 | 0 |
| 2000 | 12 | 0 |
| 2001 | 3 | 0 |
| 2002 | 5 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 7 | 0 |
| 2013 | 6 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 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? (7)
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 |
|---|---|---|---|
| * | K020594 | Diego Powered Dissector and Drill SystemSummary page 1…Manufacturer FDA Clearance Diego Powered Dissector and Drill Gyrus ENT LLC K020594 System Bartlett, TN 38133 ________ Smith & Nephew Dyonic… | 2002 |
| * | K994365 | Dyonics ElectrobladeSummary page 1…Bartlett, TN 38133 ________ Smith & Nephew Dyonics®g Smith & Nephew, Inc. K994365 ElectroBlade Tm Arthroscopy Endoscopy Division K012314 System… | 2000 |
| * | K012314 | Dyonics Electroblade ResectorSummary page 1…Smith & Nephew, Inc. K994365 ElectroBlade Tm Arthroscopy Endoscopy Division K012314 System Andover, MD 001810 K031675 Gyrus ENT Plas… | 2002 |
| * | K031675 | Smith & Nephew Dyonics Electroblade ResectorSummary page 1…Endoscopy Division K012314 System Andover, MD 001810 K031675 Gyrus ENT Plasmacisiorn Gyrus ENT LLC K021777 ___… | 2003 |
| * | K021777 | Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and…Summary page 1…Andover, MD 001810 K031675 Gyrus ENT Plasmacisiorn Gyrus ENT LLC K021777 _____ _____ _____ _____ _____Bartlett,_TN _38133 Arthrocare… | 2002 |
| * | K030108 | Arthrocare Ent Coblator Surgery SystemSummary page 1…_ _____ _____Bartlett,_TN _38133 Arthrocare ENTec Coblator Arthocare Corporation K030108 Surgery System Sunnyvale, CA 94085 Surgitron lEC II… | 2003 |
| * | K001986 | Surgitron Iec IISummary page 1…Sunnyvale, CA 94085 Surgitron lEC II Ellman International K001986 _________ ____ ____ ____ ____H ew lett,_NY _11557 _ _ _ _ _ _ _ _… | 2000 |
What descends from it? (50)
See all 506 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072302 | Entellus Medical RS-Series System | 2008 | 44 |
| K121678 | DTAD | 2012 | 2 |
| K123429 | Olympus Energy Power System (Eps) | 2013 | 1 |
| K212650 | Celeris, Disposable Sinus Debrider | 2022 | 0 |
| K152744 | Diego Elite Drill | 2016 | 0 |
| K083013 | PK Diego Powered Dissector Console, Model 7033-9050, Diego Trigger-Enabled Powered… | 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?
- The line of descent spans 10 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 5 of the 71 ancestors have a recall of any class.
- Of its descendants, K072302 (Entellus Medical, Inc., 2008) has gone furthest, with 44 descendants of its own.
- 4 other devices also cite its predicate K020594.
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 RF 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…
Read the full statement (115 words)
The Diego RF 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 & 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 as stated in the FDA summary.
https://510kreport.com/device/K034004 · printed Nov 3, 2026
Cite this page
510(k) Report. “K034004: Diego RF Powered Dissector and Drill System Console.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K034004
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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