Rusch Optosafe
FDA 510(k) K960240 · Rusch Intl.
510(k) numberK960240
Submission
- Device name
- Rusch Optosafe
- Applicant
- Rusch Intl.
Jeffrey, NH, US - Received
- January 16, 1996
- Decision date
- April 19, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CAE – Airway, Oropharyngeal, Anesthesiology
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5110
- Specialty
- Anesthesiology
Other 510(k)s with product code CAE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K130304 | Lma Family of AirwaysCAE · Traditional | The Laryngeal Mask Co., Ltd. | 05/30/2014SE |
| K033189 | King LTS Reusable Oropharyngeal Airway with Drain/Suction Channel, Models KLT 303, KLT…CAE · Special | King Systems Corp. | 05/04/2004SE |
| K033186 | King Lt-D Disposable Oropharyngeal Airway, Models KLT 203, KLT 204 and KLT 205CAE · Special | King Systems Corp. | 04/14/2004SE |
| K021634 | King LT, Models # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105CAE · Traditional | King Systems Corp. | 01/09/2003SE |
| K955721 | Cuffed Oropharyngeal Airway (Copa)CAE · Traditional | Mallinckrodt Medical | 03/28/1997SE |
| K950613 | KeiseiCAE · Traditional | Keisei (Usa) Co., Ltd. | 02/14/1996SE |
| K953400 | Guedel AirwayCAE · Traditional | Mallinckrodt Medical | 10/24/1995SE |
| K933760 | STB Guedel AirwayCAE · Traditional | Save-T-Breath Distributors C.C. | 03/23/1994SE |
| K936134 | Berman AirwayCAE · Traditional | Smiths Industries Medical Systems, Inc. | 01/28/1994SE |
| K922748 | Guedel AirwayCAE · Traditional | Oem Medical Div. | 07/10/1992SE |
More from Oem Medical Div.
| 510(k) | Device | Decision |
|---|---|---|
| K033023 | Intermittent Urethral CathetersKOD · Traditional | 12/23/2003SE |
| K030559 | Rusch Polyflex Stent for the Esophagus W/Introducer/Delivery SystemESW · Traditional | 06/30/2003SE |
| K023666 | Rusch Guided Cholangiography CatheterFGE · Traditional | 06/17/2003SE |
| K023918 | Rusch Crystal Clear Tracheostomy Sets, Cuffed and CufflessJOH · Traditional | 03/28/2003SE |
| K023964 | Rusch Microlaryngeal TubeBTR · Traditional | 12/23/2002SE |
| K021540 | Rusch Edgar TubeBTR · Traditional | 08/01/2002SE |
| K021764 | Rusch Tracheofix Set, Cuffed and UncuffedBTO · Traditional | 07/23/2002SE |
| K020714 | Rusch Floneil; Flocath IntrogelGBM · Traditional | 07/01/2002SE |
| K010798 | Rusch Cantor TubeKNT · Traditional | 02/26/2002SE |
| K010797 | Rusch Miller-Abbott TubeKNT · Traditional | 02/26/2002SE |
Questions and answers
When was Rusch Optosafe cleared by the FDA?
Rusch Optosafe (K960240) received a 510(k) decision of Substantially Equivalent on April 19, 1996, 94 days after the submission was received.
What is the product code of K960240?
The FDA product code is CAE – Airway, Oropharyngeal, Anesthesiology, a Class I (low risk) device regulated under 21 CFR 868.5110.