Neurosurical Retractors - Various Types
FDA 510(k) K892543 · Zinnanti Surgical Instruments, Inc.
510(k) numberK892543
Submission
- Device name
- Neurosurical Retractors - Various Types
- Applicant
- Zinnanti Surgical Instruments, Inc.
Chatsworth, CA, US - Received
- April 11, 1989
- Decision date
- May 5, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| 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 |
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Questions and answers
When was Neurosurical Retractors - Various Types cleared by the FDA?
Neurosurical Retractors - Various Types (K892543) received a 510(k) decision of Substantially Equivalent on May 5, 1989, 24 days after the submission was received.
What is the product code of K892543?
The FDA product code is GZT – Retractor, Self-Retaining, For Neurosurgery, a Class II (moderate risk) device regulated under 21 CFR 882.4800.