Silicone Malecot Catheter with Pezzer/Mushroom Tip
FDA 510(k) K954116 · Technical Products, Inc.
510(k) numberK954116
Submission
- Device name
- Silicone Malecot Catheter with Pezzer/Mushroom Tip
- Applicant
- Technical Products, Inc.
Decatur, GA, US - Received
- July 20, 1995
- Decision date
- November 6, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FEW – Catheter, Malecot
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5090
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FEW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K140085 | Universa Percultaneous Drainage CatheterFEW · Traditional | Cook Incorporated | 11/18/2014SE |
| K070879 | Bard Malecot and Pezzer DrainsFEW · Special | C.R. Bard, Inc. | 04/24/2007SE |
| K981258 | Manan Malecot Basket Drainage CatheterFEW · Traditional | Medical Device Technologies, Inc. | 04/22/1998SE |
| K954147 | Manan Malecot Basket Drainage CatheterFEW · Traditional | Manan Medical Products, Inc. | 03/26/1996SE |
| K920423 | Olympic Smart Scale Care CenterFEW · Traditional | Olympic Medical Corp. | 06/11/1992SE |
More from Olympic Medical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K013321 | Silicone Tracheal T-TubesBTR · Traditional | 06/04/2002SE |
| K973385 | Oval ShapesHXA · Traditional | 12/05/1997SE |
| K973166 | Dow Corning Silastic Elastomer Q7-4750MIB · Traditional | 11/21/1997SE |
| K971472 | Sil-Tec Nonreinforced Sheeting, Reinforced Sheeting, Radiopaque Sheeting, Reinforced…FTL · Traditional | 07/01/1997SE |
| K971613 | Sil-Tec Small/Large Bore Tubing/Sil-Tec High Durometer Tubing/Sil-Tec Radiopaque TubingMIB · Traditional | 05/22/1997SE |
Questions and answers
When was Silicone Malecot Catheter with Pezzer/Mushroom Tip cleared by the FDA?
Silicone Malecot Catheter with Pezzer/Mushroom Tip (K954116) received a 510(k) decision of Substantially Equivalent on November 6, 1995, 109 days after the submission was received.
What is the product code of K954116?
The FDA product code is FEW – Catheter, Malecot, a Class II (moderate risk) device regulated under 21 CFR 876.5090.