510(k) · Cleared
ClearedBoss Coagulation Device, Model BOSS1215, Boss Coagulation Device, Angled Access, Model BOSA1215
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bovie Medical · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Mar 18, 2010 as substantially equivalent to K052859 (Tissuelink Medical, Inc., 2005) and 1 other predicate after a 245-day review. Its family tree reaches back 5 generations to 1996.
- Decided
- Mar 18, 2010
- Review
- 245 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K954171 (1996). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK954171 Arco-MBC, Arco MCHoll Meditronics, Inc. · 1996
- 4 generations backK993265 Soring GMBH, Arco 3000, Arco 2000, Arco 1000, MBC 601, MBC 600Soring GmbH Medizintechnik · 1999
- 3 generations backK024059 MBC SeriesSoring GmbH Medizintechnik · 2003
- 2 generations backK052859 Aquamantys Pump Generator SystemTissuelink Medical, Inc. · 2005 · Recalled
- 1 generation backK063639 Aquamantys SS4.0 Bipolar Sealer, Model 23-121-1Tissuelink Medical, Inc. · 2007
- This deviceK092149 Boss Coagulation Device, Model BOSS1215, Boss Coagulation Device…Bovie Medical · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K954171 | Arco-MBC, Arco MC | Holl Meditronics, Inc. | 1996 | — |
| −4 | K993265 | Soring GMBH, Arco 3000, Arco 2000, Arco 1000, MBC 601, MBC 600 | Soring GmbH Medizintechnik | 1999 | — |
| −3 | K024059 | MBC Series | Soring GmbH Medizintechnik | 2003 | — |
| −2 | K052859 | Aquamantys Pump Generator System | Tissuelink Medical, Inc. | 2005 | 1 |
| −1 | K063639 | Aquamantys SS4.0 Bipolar Sealer, Model 23-121-1 | Tissuelink Medical, Inc. | 2007 | — |
| 0 (this device) | K092149 | Boss Coagulation Device, Model BOSS1215, Boss Coagulation Device, Angled… | Bovie Medical | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 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? (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 |
|---|---|---|---|
| * | K052859 | Aquamantys Pump Generator SystemSummary page 1…s II; Product Code: GEI) DEVICE DESCRIPTION: Predicate Devices: TissueLink: Aquamantys 2.3 Bipolar Sealer K-052859 TissueLink: Aquamantys 6.0 Bipolar Sealer K-052859 5-2 ===… | 2005 |
| * | K063639 | Aquamantys SS4.0 Bipolar Sealer, Model 23-121-1Summary page 3…= Page 3 === 510(k) SUMMARY (per CFR21 807.92(c)) These devices use technology substantially equivalent to the Aquarantys 554.0 Bipolar Sealer (K-063639) and the Aquamantys 6.0 Bipolar Sealer (K-052859). Both consist of an electrode tip that is used to coagulate tissue through the… | 2007 |
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?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- 3 of the 8 ancestors have a recall of any class.
- 9 other devices also cite its predicate K052859.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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?
BOSS Bipolar Operative Saline-Enhanced Sintered Steel Coagulation Devices are sterile, single-use bipolar electrosurgical devices intended to deliver RF energy and saline for coagulation of soft tissue and bone at the operative site. It is intended for but not limited to orthopedic, spine, endloscopic procedures, abdominal and thoracic surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092149 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092149: Boss Coagulation Device, Model BOSS1215, Boss Coagulation Device, Angled Access, Model BOSA1215.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092149
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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