Silclear Tubing (Modification)
FDA 510(k) K953864 · Degania Silicone , Ltd.
510(k) numberK953864
Submission
- Device name
- Silclear Tubing (Modification)
- Applicant
- Degania Silicone , Ltd.
Emek Hayarden, IL - Received
- August 7, 1995
- Decision date
- November 6, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FPK – Tubing, Fluid Delivery
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
Other 510(k)s with product code FPK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K131517 | Medrad Twist & Go High Pressure Connector TubingFPK · Special | Medrad, Inc. / Bayer Medical Care, Inc. | 08/02/2013SE |
| K063114 | Disposable Transfer Sets with and Without Swabbable Valves And/Or Check ValvesFPK · Abbreviated | Coeur, Inc. | 02/09/2007SE |
| K063239 | Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models 17528, 17527, 17525 &…FPK · Traditional | Hospira, Inc. | 12/11/2006SE |
| K052431 | Medtronic Minimed Leapfrog II Infusion Set, Models MMT-801S1, MMT-801L1, MMT-801S2…FPK · Traditional | Medtronic Minimed | 11/29/2005SE |
| K041178 | Empower Transfer Set, (Cat. No. 7725)FPK · Traditional | E-Z-Em, Inc. | 07/16/2004SE |
| K031808 | Medrad Swabbable Valve Transfer SetFPK · Special | Medrad, Inc. | 07/11/2003SE |
| K022431 | Medrad Transfer SetFPK · Traditional | Medrad, Inc. | 09/05/2002SE |
| K965208 | Polyfin Extension Set, Models 126 and 128FPK · Traditional | Medtronic Minimed | 02/26/1997SE |
| K950508 | Sysmex SF-3000FPK · Traditional | Sysmex Corp. | 11/03/1995SE |
| K952243 | Extension Set/I.V. SetFPK · Traditional | Coast Medical, Inc. | 07/26/1995SE |
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| K152246 | Aquarius Stoma Measuring DeviceKNT · Traditional | 06/21/2016SE |
| K143378 | AQUARIUS Gastrostomy Replacement TubeKNT · Special | 12/29/2014SE |
| K141753 | Aquarius Nasal Feeding TubePIF · Traditional | 10/16/2014SE |
| K141631 | Aquarius Extension Feeding SetKNT · Special | 07/28/2014SESK |
| K132686 | Aquarius Low Profile Gastrostomy Feeding TubeKNT · Traditional | 05/12/2014SESK |
| K131020 | Temperature Sensor CatheterEZL · Special | 05/09/2013SE |
| K122030 | Low Profile Gastrostomy Feeding Tube or Gastrotomey ButtonKNT · Traditional | 09/05/2012SE |
| K103371 | Coude/ or TiemannEZL · Traditional | 03/11/2011SE |
Questions and answers
When was Silclear Tubing (Modification) cleared by the FDA?
Silclear Tubing (Modification) (K953864) received a 510(k) decision of Substantially Equivalent on November 6, 1995, 91 days after the submission was received.
What is the product code of K953864?
The FDA product code is FPK – Tubing, Fluid Delivery, a Class II (moderate risk) device regulated under 21 CFR 880.5440.