Enview (TM)
FDA 510(k) K102179 · Carefusion 2200
510(k) numberK102179
Submission
- Device name
- Enview (TM)
- Applicant
- Carefusion 2200
San Diego, CA, US - Received
- August 3, 2010
- Decision date
- December 2, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OCV – Endoscope Holder
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To hold endoscope in a desired position during procedures.
Other 510(k)s with product code OCV
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240506 | KARL STORZ HoldersOCV · Traditional | Karl Storz Endoscopy America, Inc. | 10/22/2024SE |
| K232405 | Endofix ExoOCV · Traditional | Aktormed GmbH | 04/25/2024SE |
| K190576 | WalterLorenz Surgical Assist Arm Scope HolderOCV · Traditional | Biomet Microfixation | 06/05/2019SE |
| K093616 | V. Mueller Camera Controller with Storage CartOCV · Special | Carefusion 2200 | 12/23/2009SE |
| K992006 | Neuroview Instrument Holder, Model 300-33OCV · Traditional | Integra Neurocare, LLC | 08/17/1999SE |
| K990334 | Ksea Endoscope HolderOCV · Traditional | KARL STORZ Endoscopy-America, Inc. | 03/22/1999SE |
| K971584 | Clarus Model 2127-900 Series Endoscope Adater (2127-900 Series)OCV · Traditional | Clarus Medical Systems, Inc. | 05/23/1997SE |
| K960068 | SH-1 Surgical Holder for TelescopeOCV · Traditional | Olympus America, Inc. | 05/05/1997SE |
| K810787 | Urologic Tube HolderOCV · Traditional | The Urology Group | 03/31/1981SE |
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| K162432 | Multi-Link X2 ECG Cable and Lead Wire SystemDSA · Traditional | 01/18/2017SE |
| K160764 | AirLife Autofill Humidification ChamberBTT · Traditional | 08/25/2016SE |
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| K151036 | Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic InstrumentsGCJ · Traditional | 02/01/2016SE |
| K142529 | Genesis Reusable Rigid Container SystemKCT · Traditional | 01/08/2015SE |
| K140850 | Genesis Reusable Rigid Container SystemKCT · Traditional | 08/27/2014SE |
| K140761 | Kahn Uterine Cannula, Jarcho Uterine Cannula, Neal Fallopian CannulaHES · Special | 04/21/2014SE |
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Questions and answers
When was Enview (TM) cleared by the FDA?
Enview (TM) (K102179) received a 510(k) decision of Substantially Equivalent on December 2, 2010, 121 days after the submission was received.
What is the product code of K102179?
The FDA product code is OCV – Endoscope Holder, a Class II (moderate risk) device regulated under 21 CFR 876.1500.