FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEUROSURGICAL DRILLS: STILLE, HUDSON
K Number: K892531
·
Decision May 5, 1989
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
16
Applicant Total
76
Review Days
24
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Basic Information
- Device Name
- NEUROSURGICAL DRILLS: STILLE, HUDSON
- K Number
- K892531
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4300
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Zinnanti Surgical Instruments, Inc.
- Date Received
- April 11, 1989
- Decision Date
- May 5, 1989
- Product Code
- HBG
- 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 |
|---|---|---|---|
| HBG | Drills, Burrs, Trephines & Accessories (Manual) | FDA class 2 | Neurology |
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Other Clearances by Zinnanti Surgical Instruments, Inc.
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|---|---|---|---|
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| 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 |