Symmetry Sharp Kerrison Rongeur
FDA 510(k) K161744 · Symmetry Surgical, Inc.
510(k) numberK161744
Submission
- Device name
- Symmetry Sharp Kerrison Rongeur
- Applicant
- Symmetry Surgical, Inc.
Antioch, TN, US - Received
- June 24, 2016
- Decision date
- September 7, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code HAE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242759 | Geister K-Rex rongeursHAE · Traditional | Geister Medizin Technik GmbH | 06/06/2025SE |
| K223596 | SQ.line KERRISONHAE · Traditional | Aesculap, Inc. | 06/29/2023SE |
| K230256 | Rebellion, Phantom Multi-Bite Kerrison RongeurHAE · Special | Morpheus AG | 03/03/2023SE |
| K221818 | Rebellion; Phantom Multi-Bite Kerrison RongeurHAE · Special | Morpheus AG | 10/07/2022SE |
| K210741 | KLS Martin Neuro RongeursHAE · Traditional | KLS-Martin L.P. | 06/03/2022SE |
| K200768 | Rebellion, Phantom Multi-Bite Kerrison RongeurHAE · Traditional | Morpheus AG | 05/04/2021SE |
| K200387 | Ace Medical Surgical InstrumentsHAE · Traditional | Ace Medical | 07/21/2020SE |
| K200383 | Wiggins Medical Surgical InstrumentsHAE · Traditional | Wiggins Medical | 07/21/2020SE |
| K180949 | SteribiteHAE · Traditional | Rjr Surgical, Inc. | 11/08/2018SE |
| K153243 | Fehling-PunchesHAE · Traditional | Fehling Instruments GmbH & Co. KG | 08/04/2016SE |
More from Fehling Instruments GmbH & Co. KG
| 510(k) | Device | Decision |
|---|---|---|
| K173272 | Ergonomic HandleGCJ · Traditional | 02/09/2018SE |
| K152111 | Symmetry Surgical Quad-Lock Container SystemKCT · Traditional | 04/14/2016SE |
| K143078 | Bookwalter Gordon Adjustable Compression ElementDXC · Traditional | 05/14/2015SE |
| K130541 | Symmetry Kerrison Disposable Tip RongeursHAE · Traditional | 08/05/2013SE |
Questions and answers
When was Symmetry Sharp Kerrison Rongeur cleared by the FDA?
Symmetry Sharp Kerrison Rongeur (K161744) received a 510(k) decision of Substantially Equivalent on September 7, 2016, 75 days after the submission was received.
What is the product code of K161744?
The FDA product code is HAE – Rongeur, Manual, a Class II (moderate risk) device regulated under 21 CFR 882.4840.