Potts-Cournand Style Needle
FDA 510(k) K813448 · Ocean Medical Products, Ltd.
510(k) numberK813448
Submission
- Device name
- Potts-Cournand Style Needle
- Applicant
- Ocean Medical Products, Ltd.
Mchenry, IL, US - Received
- December 11, 1981
- Decision date
- January 7, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GAA – Needle, Aspiration And Injection, Disposable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
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| K962425 | Bonopty Coaxial Bone Biopsy System with Eccentric DRILL(10-1072,3,4)GAA · Traditional | Radi Medical Systems AB | 09/11/1996SE |
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More from Manan Medical Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K882013 | Soft Tissue Biopsy DeviceDWO · Traditional | 06/15/1988SE |
| K870896 | Notch-Needle, Wescott StyleGAA · Traditional | 03/18/1987SE |
| K843719 | Single Wall Introducer NeedleDYB · Traditional | 10/18/1984SE |
| K823693 | Myelography NeedleFMI · Traditional | 02/07/1983SE |
| K823692 | Spinal NeedleBSP · Traditional | 01/07/1983SE |
| K813462 | Madayag Type NeedleKNW · Traditional | 03/01/1982SE |
| K813460 | Chiba Skinny NeedleGAA · Traditional | 01/07/1982SE |
| K813461 | Percutaneous Entry Needle, SeldingerDRE · Traditional | 12/29/1981SE |
Questions and answers
When was Potts-Cournand Style Needle cleared by the FDA?
Potts-Cournand Style Needle (K813448) received a 510(k) decision of Substantially Equivalent on January 7, 1982, 27 days after the submission was received.
What is the product code of K813448?
The FDA product code is GAA – Needle, Aspiration And Injection, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.