FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEUROLOGICAL RONGEURS - VARIOUS TYPES
K Number: K892535
·
Decision May 11, 1989
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
35
Applicant Total
76
Review Days
30
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- NEUROLOGICAL RONGEURS - VARIOUS TYPES
- K Number
- K892535
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4840
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Zinnanti Surgical Instruments, Inc.
- Date Received
- April 11, 1989
- Decision Date
- May 11, 1989
- Product Code
- HAE
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HAE | Rongeur, Manual | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HAE), ordered by most recent decision date.
Geister K-Rex rongeurs
FDA 510(k)
FDA Class 2
·Neurology
SQ.line KERRISON
FDA 510(k)
FDA Class 2
·Neurology
Rebellion, Phantom Multi-Bite Kerrison Rongeur
FDA 510(k)
FDA Class 2
·Neurology
Rebellion; Phantom Multi-Bite Kerrison Rongeur
FDA 510(k)
FDA Class 2
·Neurology
KLS Martin Neuro Rongeurs
FDA 510(k)
FDA Class 2
·Neurology
Rebellion, Phantom Multi-Bite Kerrison Rongeur
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Zinnanti Surgical Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K925501 | NYLON COATED SPECULA | Jun 13, 1997 | Substantially Equivalent |
| K941458 | UTERINE MANIPULATOR/INJECTOR WITH SPRING | Jan 25, 1995 | Substantially Equivalent |
| K941457 | UTERINE INJECTOR WITH SPRING | Jan 24, 1995 | Substantially Equivalent |
| K925560 | ZSI LOOP, ZSI BALL & ZSI NEEDLE ELECTRODES | Aug 30, 1994 | Substantially Equivalent |
| K925957 | SCISSORS FOR LAPAROSCOPIC SURGERY OB/GYN USE | Jun 7, 1994 | Substantially Equivalent |
| K925960 | FORCEPS FOR LAPAROSCOPIC SURGERY OB/GYN USE | Jun 7, 1994 | Substantially Equivalent |
| K926021 | NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-OB/GYN USE | Apr 7, 1994 | Substantially Equivalent |
| K925958 | SCISSOR FOR LAPAROSCOPIC SURGERY GU USE | Mar 24, 1994 | Substantially Equivalent |
| K926181 | ZSI LAPAROSCOPES-GENERAL & PLASTIC SURGERY | Dec 17, 1993 | Substantially Equivalent |
| K926016 | NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-GU USE | Nov 12, 1993 | Substantially Equivalent |