510(k) · Cleared
ClearedBovie Inaflash Suture Remover Handle,Charger,Handle and Charger,Kit,Battery Pack
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aaron Medical Industries · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jul 18, 2006 as substantially equivalent to K840434 (Suncoast Medical Manufacturers, Inc., 1984) and 2 other predicates after a 69-day review. Its family tree reaches back 1 generation to 1984.
- Decided
- Jul 18, 2006
- Review
- 69 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K840434 (1984). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK840434 Replace-a-Tip Low Temp. CauterySuncoast Medical Manufacturers, Inc. · 1984
- This deviceK061307 Bovie Inaflash Suture Remover Handle,Charger,Handle and…Aaron Medical Industries · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K840434 | Replace-a-Tip Low Temp. Cautery | Suncoast Medical Manufacturers, Inc. | 1984 | — |
| 0 (this device) | K061307 | Bovie Inaflash Suture Remover Handle,Charger,Handle and Charger,Kit,Battery Pack | Aaron Medical Industries | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 2004 | 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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 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 |
|---|---|---|---|
| * | K840434 | Replace-a-Tip Low Temp. CauterySummary page 2…2 3 A QD Predicate Devices: Suncoast Medical Manufacturing Replace-a-Tip Cautery K840434 Pyro Tip K841591 Modern Medical Batt… | 1984 |
| * | K841591 | Pyro-TipSummary page 2…te Devices: Suncoast Medical Manufacturing Replace-a-Tip Cautery K840434 Pyro Tip K841591 Modern Medical Battery Powered Cautery K023506 Busse Hospital Disposables Sutu… | 1984 |
| * | K023506 | Surgical Medical Device CauterySummary page 2…K840434 Pyro Tip K841591 Modern Medical Battery Powered Cautery K023506 Busse Hospital Disposables Suture Removal Kit Pre-Amendment Powertron Medical Devices… | 2004 |
| * | — | Suture Removal Kit Named without a submission number | |
| * | — | Battery Pack Named without a submission number | |
| * | — | Gauze Named without a submission number | |
| * | — | Forceps 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?
- None of the 3 ancestors has a recall.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The Bovie Suture Remover is used to perform suture removal procedures in health care facilities and veterinary offices. The suture removal procedures include those in which the sutures are located externally on the surface of the skin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061307 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061307: Bovie Inaflash Suture Remover Handle,Charger,Handle and Charger,Kit,Battery Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061307
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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