FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INNOVATIVE SURGICAL(R) MANGUM KNOT PUSHER
K Number: K945394
·
Decision Jan 27, 1995
Classifications
1
FEI Numbers
573
Registration Numbers
573
Same Product Code
1391
Applicant Total
7
Review Days
85
Basic Information
- Device Name
- INNOVATIVE SURGICAL(R) MANGUM KNOT PUSHER
- K Number
- K945394
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- INNOVATIVE SURGICAL, INC.
- Date Received
- November 3, 1994
- Decision Date
- January 27, 1995
- 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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Other Clearances by INNOVATIVE SURGICAL, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K932695 | ISI(R) PORPOISE NOSE DISSECTING FORCEPS | Mar 3, 1994 | Substantially Equivalent |
| K932696 | ISI(R) CURVED, TAPERED DISSECTING FORCEPS | Mar 3, 1994 | Substantially Equivalent |
| K934075 | ISI METZENBAUM SCISSORS | Dec 1, 1993 | Substantially Equivalent |
| K932697 | ISI(R) HOOK SUTURE SCISSORS, MONOPOLAR | Nov 10, 1993 | Substantially Equivalent |
| K932698 | ISI(R) HOOK SUTURES SCISSORS | Oct 27, 1993 | Substantially Equivalent |
| K932534 | ISI FENESTRATED DISSECTING AND GRASPING FORCEPS | Aug 19, 1993 | Substantially Equivalent |