Atricure Dissector
FDA 510(k) K041681 · AtriCure, Inc.
510(k) numberK041681
Submission
- Device name
- Atricure Dissector
- Applicant
- AtriCure, Inc.
West Chester, OH, US - Received
- June 21, 2004
- Decision date
- July 1, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- FTD – Lamp, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4580
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FTD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K133425 | Scintillant Dual Bent Tip Surgical Light, Scintillant Dual Straight Tip Surgical LightFTD · Special | Engineered Medical Solutions Co., LLC | 12/05/2013SE |
| K130513 | Volista 400; Volista 600FTD · Special | Maquet S.A.S. | 05/08/2013SE |
| K123776 | Polaris 100/200FTD · Abbreviated | Drager Medical GmbH | 03/08/2013SE |
| K111020 | Atricure DissectorFTD · Special | AtriCure, Inc. | 06/09/2011SE |
| K100234 | Hm-Lamp IIFTD · Traditional | Hillusa, Inc. | 07/08/2010SE |
| K100884 | Stryker KnifelightFTD · Traditional | Howmedica Osteonics Corp. | 06/25/2010SE |
| K071180 | Scintillant Surgical Light, Model 2644-01-0001FTD · Traditional | Engineered Medical Solutions Co., LLC | 06/20/2007SE |
| K053364 | Halux Iris Examination and Surgical LampFTD · Traditional | Waldmann Lighting | 02/23/2006SE |
| K013242 | Amsco Harmony Surgical Lighting and Media SystemFTD · Abbreviated | STERIS Corporation | 12/13/2001SE |
| K010724 | Sola 700,SOLA 500, Sola 300FTD · Abbreviated | Drager Medizintechnik GmbH | 06/07/2001SE |
More from Drager Medizintechnik GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K252056 | Isolator® Synergy EnCompass Clamp and Guide system (OLH, OSH, GPM100)OCL · Special | 07/24/2025SE |
| K250371 | cryoICE cryoXT cryoablation probe (cryoXT)GXH · Traditional | 04/10/2025SE |
| K243860 | AtriClip PRO-Mini LAA Exclusion System (PROM)PZX · Special | 01/15/2025SE |
| K243157 | AtriCure cryoICE BOX (ACM)GXH · Special | 10/29/2024SE |
| K234151 | Isolator Synergy EnCapture Ablation System (EMH)OCL · Traditional | 08/27/2024SE |
| K234125 | AtriClip FLEX-Mini LAA Exclusion System (ACHM)PZX · Traditional | 07/29/2024SE |
| K233959 | EPi-Ease Epicardial Access Device (EAS)DYB · Traditional | 02/13/2024SE |
| K233407 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA…PZX · Special | 11/02/2023SE |
| K233170 | cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe…GXH · Special | 10/26/2023SE |
| K221358 | Isolator® Linear Pen (MLP1); Isolator® Transpolar Pen (MAX1, MAX5), Coolrail® Linear…OCL · Traditional | 12/30/2022SE |
Questions and answers
When was Atricure Dissector cleared by the FDA?
Atricure Dissector (K041681) received a 510(k) decision of Substantially Equivalent on July 1, 2004, 10 days after the submission was received.
What is the product code of K041681?
The FDA product code is FTD – Lamp, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.4580.