Crystal Vision #250D Smoke Evacuator System with Accessories
FDA 510(k) K003840 · I.C Medical, Inc.
510(k) numberK003840
Submission
- Device name
- Crystal Vision #250D Smoke Evacuator System with Accessories
- Applicant
- I.C Medical, Inc.
Phoenix, AZ, US - Received
- December 12, 2000
- Decision date
- February 1, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FYD – Apparatus, Exhaust, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5070
- Specialty
- General, Plastic Surgery
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|---|---|---|---|
| K240127 | PlumeSafe X5 Smoke Management SystemFYD · Traditional | Conmed Corporation | 08/05/2024SE |
| K233789 | 8Q10 Surclear Smoke Plume Evacuation SystemFYD · Traditional | Surnic Corporation | 04/10/2024SE |
| K213068 | Medline Smoke Evacuation ShroudFYD · Traditional | Medline Industries, Inc. | 01/03/2022SE |
| K202944 | NEBULAE SRS Laparoscopic Surgical Smoke Removal SystemFYD · Traditional | Northgate Technologies, Inc. | 03/25/2021SE |
| K200250 | Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable…FYD · Traditional | Megadyne Medical Products, Inc. | 06/26/2020SE |
| K192035 | EvaQMax Smoke Evacuation SystemFYD · Traditional | Bio Protech, Inc. | 08/29/2019SE |
| K191328 | Megadyne Foot SwitchFYD · Traditional | Megadyne Medical Products, Inc. | 07/26/2019SE |
| K182224 | SafeAir Smoke Evacuator compactFYD · Traditional | Lina Medical Aps | 02/07/2019SE |
| K173108 | SmokleanFYD · Traditional | Sejong Medical Co., Ltd. | 05/18/2018SE |
| K163659 | Crystal VisionFYD · Special | I.C Medical, Inc. | 10/30/2017SE |
More from I.C Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K163659 | Crystal VisionFYD · Special | 10/30/2017SE |
| K160160 | Non-Telescopic PenEvacGEI · Special | 04/05/2016SE |
| K960492 | Si Controller Model Si 500BTA · Traditional | 12/23/1996SE |
| K961616 | Telescoping Penevac (Modification)GEI · Traditional | 05/28/1996SE |
| K955166 | Penevac Si.GEI · Traditional | 04/11/1996SE |
| K955020 | Penevac Abc HandpieceGEI · Traditional | 04/09/1996SE |
| K953418 | Electrocautery ShroudGCJ · Traditional | 10/07/1995SE |
| K954088 | Telescoping PenevacGEI · Traditional | 09/22/1995SE |
| K932230 | Crystal Vision and AccessoriesFYD · Traditional | 02/18/1994SE |
| K930099 | Laser Handpiece ShroudGEX · Traditional | 07/28/1993SE |
Questions and answers
When was Crystal Vision #250D Smoke Evacuator System with Accessories cleared by the FDA?
Crystal Vision #250D Smoke Evacuator System with Accessories (K003840) received a 510(k) decision of Substantially Equivalent on February 1, 2001, 51 days after the submission was received.
What is the product code of K003840?
The FDA product code is FYD – Apparatus, Exhaust, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.5070.