Smith & Nephew Off-Centered Porp
FDA 510(k) K002464 · Gyrus Ent LLC
510(k) numberK002464
Submission
- Device name
- Smith & Nephew Off-Centered Porp
- Applicant
- Gyrus Ent LLC
Bartlett, TN, US - Received
- August 10, 2000
- Decision date
- August 29, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K040996 | Retrox Titanium Tube System for the Retrox Transcutaneous Air Conduction Hearing Aid…NIX · Traditional | 08/20/2004SE |
| K034004 | Diego RF Powered Dissector and Drill System ConsoleERL · Traditional | 03/03/2004SE |
| K033089 | Hemostatix, Model 2400Z Thermal Scalpel SystemGEI · Traditional | 02/05/2004SE |
| K033554 | Smart Offset Stapes Piston; Smart Isj ProsthesisETB · Traditional | 11/24/2003SE |
| K030343 | Diego Powered Dissector Handpiece with Starlink Image-Guided Adapter Mounting InterfaceHAW · Traditional | 05/02/2003SE |
| K021595 | Gyrus ENT Nerve StimulatorETN · Traditional | 10/24/2002SE |
| K021777 | Gyrus ENT Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and…GEI · Traditional | 08/26/2002SE |
| K020778 | Gyrus ENT Somnoplasty Tissue Coagulating Electrode, Model 2420GEI · Traditional | 05/28/2002SE |
| K020067 | Gyrus ENT Somnoplasty GeneratorGEI · Traditional | 04/04/2002SE |
| K020594 | Diego Powered Dissector and Drill SystemERL · Traditional | 03/08/2002SE |
Questions and answers
When was Smith & Nephew Off-Centered Porp cleared by the FDA?
Smith & Nephew Off-Centered Porp (K002464) received a 510(k) decision of Substantially Equivalent on August 29, 2000, 19 days after the submission was received.
What is the product code of K002464?
The FDA product code is ETB – Prosthesis, Partial Ossicular Replacement, a Class II (moderate risk) device regulated under 21 CFR 874.3450.