FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SCISSOR FOR LAPAROSCOPIC SURGERY GU USE
K Number: K925958
·
Decision Mar 24, 1994
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
76
Review Days
485
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Basic Information
- Device Name
- SCISSOR FOR LAPAROSCOPIC SURGERY GU USE
- K Number
- K925958
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Zinnanti Surgical Instruments, Inc.
- Date Received
- November 24, 1992
- Decision Date
- March 24, 1994
- Product Code
- GCJ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | FDA class 2 | Gastroenterology, Urology |
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FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air)
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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 |
| 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 |
| K925959 | FORCEPS FOR LAPAROSCOPIC SURGERY GU USE | Nov 12, 1993 | Substantially Equivalent |