Neurological Rongeurs - Various Types
FDA 510(k) K892535 · Zinnanti Surgical Instruments, Inc.
510(k) numberK892535
Submission
- Device name
- Neurological Rongeurs - Various Types
- Applicant
- Zinnanti Surgical Instruments, Inc.
Chatsworth, CA, US - Received
- April 11, 1989
- Decision date
- May 11, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| 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 |
| K161744 | Symmetry Sharp Kerrison RongeurHAE · Special | Symmetry Surgical, Inc. | 09/07/2016SE |
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| K925560 | Zsi Loop, Zsi Ball & Zsi Needle ElectrodesHGI · Traditional | 08/30/1994SE |
| K925960 | Forceps for Laparoscopic Surgery OB/GYN UseHFI · Traditional | 06/07/1994SE |
| K925957 | Scissors for Laparoscopic Surgery OB/GYN UseHFI · Traditional | 06/07/1994SE |
| K926021 | Needle Holders & Access for Lapar Surg-Ob/Gyn UseHET · Traditional | 04/07/1994SE |
| K925958 | Scissor for Laparoscopic Surgery Gu UseGCJ · Traditional | 03/24/1994SE |
| K926181 | Zsi Laparoscopes-General & Plastic SurgeryGCJ · Traditional | 12/17/1993SE |
| K926016 | Needle Holders & Access for Lapar Surg-Gu UseGCJ · Traditional | 11/12/1993SE |
Questions and answers
When was Neurological Rongeurs - Various Types cleared by the FDA?
Neurological Rongeurs - Various Types (K892535) received a 510(k) decision of Substantially Equivalent on May 11, 1989, 30 days after the submission was received.
What is the product code of K892535?
The FDA product code is HAE – Rongeur, Manual, a Class II (moderate risk) device regulated under 21 CFR 882.4840.