510(k) · Cleared
ClearedAmbient Turboflash 90 Ifs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthocare Corporation · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Dec 11, 2012 as substantially equivalent to K083306 (Arthrocare Corp., 2008) after a 271-day review. Its family tree reaches back 13 generations to 2001. 4 later devices descend from it.
- Decided
- Dec 11, 2012
- Review
- 271 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K011083 (2001). 25 ancestors in all, the oldest K000778 (2000). 4 later devices descend from it, 2 citing it directly.
- Root · 13 generations backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
- 9 generations between
- 3 generations backK082323 Arthrocare ArthrowandsArthrocare Corp. · 2008
- 2 generations backK082980 Arthrocare ArthrowandsArthrocare Corp. · 2008 · Recalled
- 1 generation backK083306 Modification to Arthrocare ArthrowandsArthrocare Corp. · 2008 · Recalled
- This deviceK120791 Ambient Turboflash 90 IfsArthocare Corporation · 2012
- Descendant · cites it directly · 3 of its ownK152777 Bovie Disposable Bipolar AblatorBovie Medical Corporation · 2016 · Recalled
- Descendant · cites it directly · 2 of its ownK161558 Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and…Bovie Medical Corporation · 2016 · Recalled
- Descendant · 2 generations on · 1 of its ownK231126 Eblator DeviceE Surgical, LLC · 2023
- Descendant · 3 generations on · 0 of its ownK251899 E BlatorNew Deantronics Taiwan, Ltd. · 2025
Show all 13 generations
- Root · 13 generations backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
- 12 generations backK013463 Arthrocare Arthro Wands, Enetec Evac Plasma WandArthrocare Corp. · 2001
- 11 generations backK020557 Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord…Arthrocare Corp. · 2002
- 10 generations backK030551 Arthrocare Controller (System 2000 and 8000); Arthrocare Patient…Arthrocare Corp. · 2003 · Recalled
- 9 generations backK032504 Arthrocare SystemArthrocare Corp. · 2003
- 8 generations backK033584 Arthrocare ArthrowandsArthrocare Corp. · 2003 · Recalled
- 7 generations backK052686 Arthrocare ArthrowandsArthrocare Corp. · 2005
- 6 generations backK070958 Modification to Arthrocare ArthrowandsArthrocare Corp. · 2007
- 5 generations backK071963 Modification to: Arthrocare ArthrowandsArthrocare Corp. · 2007
- 4 generations backK072865 Modificaton to: Arthrocare ArthrowandsArthrocare Corp. · 2007
- 3 generations backK082323 Arthrocare ArthrowandsArthrocare Corp. · 2008
- 2 generations backK082980 Arthrocare ArthrowandsArthrocare Corp. · 2008 · Recalled
- 1 generation backK083306 Modification to Arthrocare ArthrowandsArthrocare Corp. · 2008 · Recalled
- This deviceK120791 Ambient Turboflash 90 IfsArthocare Corporation · 2012
Most influential descendants
Showing 4 of 4 · See all- K152777Bovie Disposable Bipolar AblatorBovie Medical Corporation · 2016 · cites it directly3descendants
- K161558Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm…Bovie Medical Corporation · 2016 · cites it directly2descendants
- K231126Eblator DeviceE Surgical, LLC · 2023 · 2 generations on1descendant
- K251899E BlatorNew Deantronics Taiwan, Ltd. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K011083 | Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare… | Arthrocare Corp. | 2001 | — |
| −12 | K013463 | Arthrocare Arthro Wands, Enetec Evac Plasma Wand | Arthrocare Corp. | 2001 | — |
| −11 | K020557 | Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands | Arthrocare Corp. | 2002 | — |
| −10 | K030551 | Arthrocare Controller (System 2000 and 8000); Arthrocare Patient Cable; Foot… | Arthrocare Corp. | 2003 | 1 |
| −9 | K032504 | Arthrocare System | Arthrocare Corp. | 2003 | — |
| −8 | K033584 | Arthrocare Arthrowands | Arthrocare Corp. | 2003 | 1 |
| −7 | K052686 | Arthrocare Arthrowands | Arthrocare Corp. | 2005 | — |
| −6 | K070958 | Modification to Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
| −5 | K071963 | Modification to: Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
| −4 | K072865 | Modificaton to: Arthrocare Arthrowands | Arthrocare Corp. | 2007 | — |
| −3 | K082323 | Arthrocare Arthrowands | Arthrocare Corp. | 2008 | — |
| −2 | K082980 | Arthrocare Arthrowands | Arthrocare Corp. | 2008 | 12 |
| −1 | K083306 | Modification to Arthrocare Arthrowands | Arthrocare Corp. | 2008 | 1 |
| 0 (this device) | K120791 | Ambient Turboflash 90 Ifs | Arthocare Corporation | 2012 | — |
| +1 | K152777 | Bovie Disposable Bipolar Ablator | Bovie Medical Corporation | 2016 | 2 |
| +1 | K161558 | Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating… | Bovie Medical Corporation | 2016 | 3 |
| +2 | K231126 | Eblator Device | E Surgical, LLC | 2023 | — |
| +3 | K251899 | E Blator | New Deantronics Taiwan, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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? (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 | Decided |
|---|---|---|---|
| * | K083306 | Modification to Arthrocare ArthrowandsSummary page 1…: GE1 CFR Section: 21 CFR 878.4400 Predicate Device Ambient Super TurboVac* 90 IFS Wand included in: ArthroCare ArthroWand Devices, K083306 Product Description The Ambient TurboFlash 90 IFS Wand is a bipolar, sterile, single-use, high frequency electrosur… | 2008 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 11 years and passes through 2 companies; a new generation was cleared every 5 months on median.
- 4 of the 25 ancestors have a recall of any class.
- Of its descendants, K152777 (Bovie Medical Corporation, 2016) has gone furthest, with 3 descendants of its own.
- 7 other devices also cite its predicate K083306.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
The Ambient TurboFlash 90 IFS Wand is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures: Ablation and Debridement * ACL/PCL — Knee * Acromioplasty — Shoulder * Articular Cartilage — All Joints * Bursectomy — All Joints * Chondroplasty — All Joints * Fascia — All Joints * Ligament — All Joints * Notchplasty — Knee * Scar Tissue — All Joints * Soft Tissue — All Joints…
Read the full statement (254 words)
The Ambient TurboFlash 90 IFS Wand is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures:
Ablation and Debridement
* ACL/PCL — Knee
* Acromioplasty — Shoulder
* Articular Cartilage — All Joints
* Bursectomy — All Joints
* Chondroplasty — All Joints
* Fascia — All Joints
* Ligament — All Joints
* Notchplasty — Knee
* Scar Tissue — All Joints
* Soft Tissue — All Joints
* Subacromial Decompression — Shoulder
* Synovectomy — All Joints
* Tendon — All Joints
Excision and Resection
* Acetabular Labrum — Hip
* Articular Labrum — All Joints
* Capsule — All Joints
* Capsular Release — Knee
* Cartilage Flaps — Knee
* Cysts — All Joints
* Discoid Meniscus — Knee
* Frozen Shoulder Release — Shoulder
* Glenoid Labrum — Shoulder
* Lateral Release — Knee
* Ligament — All Joints
* Loose Bodies — All Joints
* Meniscal Cystectomy — Knee
* Meniscectomy — Knee
* Plica Removal — All Joints
* Scar Tissue — All Joints
* Soft Tissue — All Joints
* Synovial Membrane — All Joints
* Tendon — All Joints
* Triangular Fibrocartilage (TFCC) — Wrist
* Villusectomy — Knee
Coagulation
* ACL/PCL — Knee
* Articular Cartilage — All Joints
* Carpal Ligaments — Wrist
* Glenohumeral Capsule — Shoulder
* Ligament — All Joints
* Medial Retinaculum — Knee
* Rotator Cuff — Shoulder
* Tendon — All Joints
* Wrist Tendons — Wrist
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120791 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120791: Ambient Turboflash 90 Ifs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120791
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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