PTFE Piston
FDA 510(k) K913285 · River Medical, Inc.
510(k) numberK913285
Submission
- Device name
- PTFE Piston
- Applicant
- River Medical, Inc.
Memphis, TN, US - Received
- July 24, 1991
- Decision date
- December 18, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- ETB – Prosthesis, Partial Ossicular Replacement
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3450
- Specialty
- Ear, Nose, Throat
- Implant
- Yes
Other 510(k)s with product code ETB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260720 | mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm)…ETB · Special | MED-EL Elektromedizinische Geräte GmbH | 04/03/2026SE |
| K260718 | mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm)…ETB · Special | MED-EL Elektromedizinische Geräte GmbH | 04/03/2026SE |
| K241261 | mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and…ETB · Traditional | MED-EL Elektromedizinische Geräte GmbH | 01/17/2025SE |
| K241142 | mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes…ETB · Traditional | MED-EL Elektromedizinische Geräte GmbH | 01/17/2025SE |
| K130512 | Nitiflex Stapes Prosthesis, Detroit Piston, Skarzynski Piston, Roberson Stapes ProsthesisETB · Traditional | Heinz Kurz GmbH Medizintechnik | 12/02/2013SE |
| K112616 | Nitibond Stapes Prosthesis, Nitiplast Stapes ProsthesisETB · Traditional | Heinz Kurz GmbH Medizintechnik | 02/08/2013SE |
| K080070 | K-Helix Piston and Porp Partial Ossicular Replacement ProsthesesETB · Traditional | Grace Medical, Inc. | 04/17/2008SE |
| K063374 | Nitinol Locking Incudo-Stapedial Joint, Angular Piston, Piston, Malleus Piston, Porp and…ETB · Traditional | Grace Medical, Inc. | 12/06/2006SE |
| K061853 | Grace Medical Adjustable and Fixed Length Partial & Total Ossicular Replacement ProsthesesETB · Traditional | Grace Medical, Inc. | 08/18/2006SE |
| K060518 | Partial Ossicular Replacement ProsthesesETB · Traditional | Grace Medical, Inc. | 06/28/2006SE |
More from Grace Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K023174 | Disposable Temporary Pacing WireLDF · Traditional | 06/11/2003SE |
| K944352 | Smartdose III Infusion ContainerFRN · Traditional | 11/15/1995ST |
| K944351 | Smartdose IV Prefilled Infusion ContainerFRN · Traditional | 11/15/1995ST |
| K945298 | Smartflow I Administration SetFPA · Traditional | 06/14/1995SE |
| K943692 | Smart Dose(Tm)FRN · Traditional | 04/28/1995ST |
| K932895 | River PumpFRN · Traditional | 03/31/1994SE |
| K933335 | River Vial AdapterFMF · Traditional | 03/01/1994SE |
| K915120 | Tef/Platinum PistonETB · Traditional | 12/27/1991SE |
| K915121 | Tef/Wire PistonETB · Traditional | 12/23/1991SE |
| K913287 | H/A Partial - Regular & H/A Partial - OffsetETB · Traditional | 12/18/1991SE |
Questions and answers
When was PTFE Piston cleared by the FDA?
PTFE Piston (K913285) received a 510(k) decision of Substantially Equivalent on December 18, 1991, 147 days after the submission was received.
What is the product code of K913285?
The FDA product code is ETB – Prosthesis, Partial Ossicular Replacement, a Class II (moderate risk) device regulated under 21 CFR 874.3450.