510(k) · Cleared
ClearedReprocessed Ent Shavers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sterilmed, Inc. · ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Cleared on Dec 17, 2008 after a 174-day review. Our reading found no predicate number; beside “510(k)” the summary prints a number our reading could not make out (“7013-8100”).
- Decided
- Dec 17, 2008
- Review
- 174 days
- Class
- Class II
- Product code
- ERL
- Recalls
- None
- Predicates
- 0
Our reading found no predicate number; beside “510(k)” the summary prints a number our reading could not make out (“7013-8100”).
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? (2)
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 |
|---|---|---|---|
| * | — | Gyrus Diego shavers Named without a submission number | |
| * | — | Medtronic Xomed XPS shavers 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.
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. 2008, this device’s year, is highlighted.
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 reprocessed ENT shavers are intended to be used with a reusable hand piece and are designed for use in various ENT, head and neck surgeries and otoneurologic procedures. Sinus Applications: * Polypectomy * Ethmoidectomy/Sphenoethmoidectomy * Septoplasty * Antrostomy * Endoscopic DCR * Frontal Sinus Trephination and Irrigation * Frontal Sinus Drill Out * Septal Spur Removal * Trans-Sphenoidal Procedures Head and Neck Procedures * Rhinoplasty…
Read the full statement (105 words)
The reprocessed ENT shavers are intended to be used with a reusable hand piece and are designed for use in various ENT, head and neck surgeries and otoneurologic procedures.
Sinus Applications:
* Polypectomy
* Ethmoidectomy/Sphenoethmoidectomy
* Septoplasty
* Antrostomy
* Endoscopic DCR
* Frontal Sinus Trephination and Irrigation
* Frontal Sinus Drill Out
* Septal Spur Removal
* Trans-Sphenoidal Procedures
Head and Neck Procedures
* Rhinoplasty
Lipodebridement in the Maxillary and Mandibular Region
* Soft Tissue Shaving
* Acoustic Neuroma Removal
Nasopharyngeal and Laryngeal Procedures
* Tonsillectomy
* Tracheal Procedures
* Adenoidectomy
* Laryngeal Lesion De-Bulking
* Laryngeal Polypectomy
Otology Procedures
* Mastoidotomy
* Mastoidectomy
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081814 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081814: Reprocessed Ent Shavers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081814
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026