510(k) · Cleared
ClearedEssential Shaver System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gyrus Ent LLC · EQJ Bur, Ear, Nose And Throat
Cleared on Jan 12, 1998 as substantially equivalent to K953096 (Smith & Nephew Richards, Inc., 1995) after a 61-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Jan 12, 1998
- Review
- 61 days
- Class
- Class I
- Product code
- EQJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K953096 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK953096 Essential Shaver SystemSmith & Nephew Richards, Inc. · 1995
- This deviceK974232 Essential Shaver SystemGyrus Ent LLC · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953096 | Essential Shaver System | Smith & Nephew Richards, Inc. | 1995 | — |
| 0 (this device) | K974232 | Essential Shaver System | Gyrus Ent LLC | 1998 | — |
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 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? (3)
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 |
|---|---|---|---|
| * | K953096 | Essential Shaver SystemSummary page 1…Smith--Nephew ] 510(k) Summary of Safety and Effectiveness JN 12 jg98 KRG 74230 Trade Name: ESSential® Shaver System Modification to the ESSential® Sinus Shaver System (K953096) Common Name: Electrical Surgical Shaver Classification Name: Surgical ENT drill, electric or pneumatic including handpiece and E… | 1995 |
| * | — | Xomed XPS System used with the STRAIGHTSHOT, PERFORMA and SKEETER handpieces Named without a submission number | |
| * | — | ESSential Shaver System Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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.
- 3 other devices also cite its predicate K953096.
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 | — |
What is it indicated for?
The ESSential Shaver System is presently intended for the removal of soft tissue and small amounts of bony obstruction secondary to chronic sinus disease. The modification to this system would expand its intended use to the cutting and removal of bone and tissue in general ENT, head & neck, and otoneurologic procedures. Otology procedures could include mastoidectomy and mastoidotomy. Sinus applications would embody septoplasty and procedures such as the…
Read the full statement (146 words)
The ESSential Shaver System is presently intended for the removal of soft tissue and small
amounts of bony obstruction secondary to chronic sinus disease. The modification to this system
would expand its intended use to the cutting and removal of bone and tissue in general ENT,
head & neck, and otoneurologic procedures. Otology procedures could include mastoidectomy
and mastoidotomy. Sinus applications would embody septoplasty and procedures such as the
removal of septal spurs, polypectomy, antrostomy, ethmoidectomy/sphenoethmoidectomy,
frontal sinus trephination and irrigation, frontal sinus drill out, endoscopic DCR and trans-
spehnoidal procedures. Nasopharyngeal/Laryngeal procedures would comprise adenoidectomy,
laryngeal lesion debulking and tonsillectomy. Head and neck procedures would encompass soft
tissue shaving, rhinoplasty (narrowing of the bony vault and revision of the bony pyramid),
removal of fatty (adipose) tissue (lipo debridement) in the maxillary and mandibular regions of
the face, and acoustic neuroma removal at the cerebellopontine angle.
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/K974232 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974232: Essential Shaver System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974232
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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