Faller Trocar
FDA 510(k) K120130 · Medigroup, Inc.
510(k) numberK120130
Submission
- Device name
- Faller Trocar
- Applicant
- Medigroup, Inc.
Oswego, IL, US - Received
- January 17, 2012
- Decision date
- May 21, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FJS – Catheter, Peritoneal, Long-Term Indwelling
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5630
- Specialty
- Gastroenterology, Urology
- Implant
- Yes
Other 510(k)s with product code FJS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K213602 | Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter…FJS · Traditional | Covidien, LLC | 01/14/2022SE |
| K180485 | Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis…FJS · Traditional | Covidien, LLC | 07/27/2018SESK |
| K130441 | Faller StyletFJS · Traditional | Medionics International, Inc. | 04/19/2013SE |
| K121383 | PS X Series (Basic Components and Catheter), PD X Series (Catheter with All Components)FJS · Traditional | Medical Components, Inc. | 09/05/2012SESK |
| K113354 | Veta Peritoneal Dialysis CatheterFJS · Traditional | Pfm Medical, Inc. | 03/13/2012SESK |
| K071167 | Flex-Neck Exxtended Peritoneal Dialysis Catheter and Accessories, Model CF-5560FJS · Traditional | Medigroup, Inc. | 08/31/2007SESK |
| K070730 | Flex-Neck Arc CatheterFJS · Traditional | Medigroup, Inc. | 07/03/2007SESK |
| K060897 | Embedding Tool, Model TE-1000FJS · Traditional | Medigroup, Inc. | 07/18/2006SE |
| K053123 | PD CathFJS · Traditional | Med-Conduit, Inc. | 03/29/2006SE |
| K031351 | Flex-Neck PD Catheter, InfantFJS · Traditional | Medigroup, Inc. | 09/17/2003SE |
More from Medigroup, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K071167 | Flex-Neck Exxtended Peritoneal Dialysis Catheter and Accessories, Model CF-5560FJS · Traditional | 08/31/2007SESK |
| K070730 | Flex-Neck Arc CatheterFJS · Traditional | 07/03/2007SESK |
| K060897 | Embedding Tool, Model TE-1000FJS · Traditional | 07/18/2006SE |
| K031351 | Flex-Neck PD Catheter, InfantFJS · Traditional | 09/17/2003SE |
| K974570 | Peritoneal Dialysis Catheter ConnectorFKO · Traditional | 02/27/1998SE |
| K823294 | Medigroup LS-110 Light SourceHET · Traditional | 05/09/1983SE |
| K823297 | ST-610 Needlescope Sterilization TrayHET · Traditional | 05/06/1983SE |
| K823295 | Medigroup 2.2MM Needlescope Cannula&HET · Traditional | 05/06/1983SE |
| K823293 | Medigroup LG-102 Light GuideHET · Traditional | 05/05/1983SE |
| K823390 | PC 201A Locking SleeveFKX · Traditional | 01/26/1983SE |
Questions and answers
When was Faller Trocar cleared by the FDA?
Faller Trocar (K120130) received a 510(k) decision of Substantially Equivalent on May 21, 2012, 125 days after the submission was received.
What is the product code of K120130?
The FDA product code is FJS – Catheter, Peritoneal, Long-Term Indwelling, a Class II (moderate risk) device regulated under 21 CFR 876.5630.