Topical Applicator
FDA 510(k) K070596 · Sharn, Inc.
510(k) numberK070596
Submission
- Device name
- Topical Applicator
- Applicant
- Sharn, Inc.
Bonita Springs, FL, US - Received
- March 2, 2007
- Decision date
- June 21, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CCT – Applicator (Laryngo-Tracheal), Topical Anesthesia
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5170
- Specialty
- Anesthesiology
Other 510(k)s with product code CCT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240114 | UltraEzAir® (UEA1A)CCT · Traditional | Dualams, Inc., Dba Airkor | 10/16/2024SE |
| K172956 | Medicant Mucosal AtomizerCCT · Traditional | Medica Holdings, LLC | 04/06/2018SE |
| K153470 | MADgic Laryngo-Tracheal Mucosal Atomization DeviceCCT · Traditional | Teleflex Medical | 08/19/2016SE |
| K093584 | Ez-MisterCCT · Traditional | N.M. Beale Co., Inc. | 03/04/2011SE |
| K002255 | Laryngo-Tracheal Mucosal Atomization Device (Madgic)CCT · Traditional | Wolfe Tory Medical, Inc. | 09/18/2000SE |
| K894755 | Astra Disposable Spray CannulaCCT · Traditional | Astra Pharmaceutical Products, Inc. | 01/12/1990SE |
| K810059 | Endo-Med Tube for Endotracheal MedCCT · Traditional | Ackrad Laboratories | 02/26/1981SE |
| K760877 | Monoject Laryngotracheal Anesthesia KitCCT · Traditional | Sherwood Medical Industries | 12/09/1976SE |
| K760759 | Anesthesia KitCCT · Traditional | Sherwood Medical Industries | 12/09/1976SE |
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Questions and answers
When was Topical Applicator cleared by the FDA?
Topical Applicator (K070596) received a 510(k) decision of Substantially Equivalent on June 21, 2007, 111 days after the submission was received.
What is the product code of K070596?
The FDA product code is CCT – Applicator (Laryngo-Tracheal), Topical Anesthesia, a Class II (moderate risk) device regulated under 21 CFR 868.5170.