510(k) · Cleared

Cleared

Diego Powered Dissector Handpiece with Starlink Image-Guided Adapter Mounting Interface

K030343510(k) TraditionalCleared May 2, 200388-day reviewClass II21 CFR 882.4560

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Gyrus Ent LLC · HAW Neurological Stereotaxic Instrument

Cleared on May 2, 2003 as substantially equivalent to K020594 (Gyrus Ent LLC, 2002) after an 88-day review. Its family tree reaches back 1 generation to 2002. 3 later devices descend from it.

Decided: May 2, 2003
Review: 88 days
Class: Class II
Product code: HAW
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K020594 (2002). 3 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK020594 Diego Powered Dissector and Drill SystemGyrus Ent LLC · 2002
This deviceK030343 Diego Powered Dissector Handpiece with Starlink Image-Guided Adapter…Gyrus Ent LLC · 2003
Descendant · cites it directly · 1 of its ownK123429 Olympus Energy Power System (Eps)Gyrus Acmi, Inc. · 2013 · Recalled
Descendant · 2 generations on · 0 of its ownK212650 Celeris, Disposable Sinus DebriderGyrus Acmi, Inc. · 2022
Descendant · cites it directly · 0 of its ownK080052 Stryker Essx with Navigation MountStryker Corp. · 2008

Most influential descendants

Showing 3 of 3 · See all

K123429Olympus Energy Power System (Eps)Gyrus Acmi, Inc. · 2013 · cites it directly1descendant
K212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc. · 2022 · 2 generations on0descendants
K080052Stryker Essx with Navigation MountStryker Corp. · 2008 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K020594	Diego Powered Dissector and Drill System	Gyrus Ent LLC	2002	—
0 (this device)	K030343	Diego Powered Dissector Handpiece with Starlink Image-Guided Adapter Mounting…	Gyrus Ent LLC	2003	—
+1	K123429	Olympus Energy Power System (Eps)	Gyrus Acmi, Inc.	2013	12
+2	K212650	Celeris, Disposable Sinus Debrider	Gyrus Acmi, Inc.	2022	—
+1	K080052	Stryker Essx with Navigation Mount	Stryker Corp.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2013	1	0
2022	1	0

FIG. 1 — Lineage of K030343, 2002–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 HAW? 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 HAW device

#1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 11 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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	Applicant	Decided	Recalls
*	K020594	Diego Powered Dissector and Drill System Summary page 1 …Device Product Code HAW Subiect Device Description The Diego Powered Dissector and Drill System Handpiece, cleared under 51O(k) K020594, has been modified to accept the BrainLAB VectorVision (K003589) and Kolibri (KO14256) Image-Guided Surgery System Instrumen…	Gyrus Ent LLC	2002	—

Also cleared against K020594: 4 other devices →

What descends from it? (3)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K123429	Olympus Energy Power System (Eps)	Gyrus Acmi, Inc.	2013	1
K080052	Stryker Essx with Navigation Mount	Stryker Corp.	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?

Its one ancestor has no recall.
Of its descendants, K123429 (Gyrus Acmi, Inc., 2013) has gone furthest, with 1 descendant of its own.
4 other devices also cite its predicate K020594.

How does its category compare?

All HAW devices

HAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HAW

9in 2025

2007high 15 (2007) · low 3 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HAW

163in 2025

2007high 238 (2014) · low 66 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HAW

2in 2025

2007high 28 (2010) · low 1 (2020)2026

Class I (9 since 2007) Class II/III not classified

Adverse event reports per year · HAW

3,425in 2025

2007high 6,062 (2019) · low 49 (2007)2025

MAUDE reports naming product code HAW, 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	15	107	2	49
2008	12	112	10	53
2009	8	221	6	96
2010	6	138	28	299
2011	4	66	5	1,725
2012	8	178	4	986
2013	3	172	6 (1)	1,290
2014	5	238	5	1,606
2015	10	232	3	1,767
2016	9	175	5	1,828
2017	7	226	2	3,505
2018	6	112	2 (2)	4,439
2019	10	147	4 (1)	6,062
2020	5	88	1	3,480
2021	9	168	4 (2)	2,827
2022	7	128	1	1,929
2023	14	142	4 (1)	2,510
2024	7	107	2 (2)	3,755
2025	9	163	2	3,425
2026	5	162	6	—

What is it indicated for?

The intended use of the Diego Powered Dissector and Drill System is the cutting and removal of bone and tissue in general ENT, Head & Neck, and atoneurologic procedures. Sinus applications would embody: ethrnoidectomy/sphenoethmoidectomy polypectomy septoplasty and procedures such as antrostomy endoscopic DCR frontal sinus drill-out frontal sinus trephination and irrigation septal spurs removal trans-spehn oidal procedures NasopharyngeaIAaryngeal…

Read the full statement (115 words)

The intended use of the Diego Powered Dissector and Drill System is the cutting and removal of bone and tissue in general ENT, Head & Neck, and atoneurologic procedures.

Sinus applications would embody:

ethrnoidectomy/sphenoethmoidectomy

polypectomy

septoplasty and procedures such as

antrostomy

endoscopic DCR

frontal sinus drill-out

frontal sinus trephination and irrigation

septal spurs removal

trans-spehn oidal procedures

NasopharyngeaIAaryngeal procedures would comprise:

adenoidedomy

laryngeal lesion de-bulking

laryngeal polypectomy

tracheal procedures

tonsillectomy

Otology procedures would include:

mastoidectomy

mastoidotomy.

Head & Neck procedures would encompass:

soft tissue shaving

rhinoplasty (narrowlng 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

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030343 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030343: Diego Powered Dissector Handpiece with Starlink Image-Guided Adapter Mounting Interface.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030343

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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