FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VERRSS PNEUMO NEEDLE
K Number: K931850
·
Decision Apr 7, 1994
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
21
Review Days
359
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Basic Information
- Device Name
- VERRSS PNEUMO NEEDLE
- K Number
- K931850
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Advanced Surgical, Inc.
- Date Received
- April 13, 1993
- Decision Date
- April 7, 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 Advanced Surgical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K950126 | ENDOSCOPIC LIGATION DEVICE, LIGATOR HANDLE, LIGATOR CARTRIDGE | Apr 13, 1995 | Substantially Equivalent |
| K950005 | TROCAR CANNULA STABILIZER | Jan 18, 1995 | Substantially Equivalent |
| K945369 | LAPAROSCOPIC SURGICAL INSTRUMENTS FOR GENERAL USE | Nov 22, 1994 | Substantially Equivalent |
| K933497 | LAPAROSCOPIC COVERED SURGICAL RETRACTOR | May 12, 1994 | Substantially Equivalent |
| K941500 | TISSUE ISOLATION AND RETRIEVAL BAG | Apr 19, 1994 | Substantially Equivalent |
| K934807 | PUNCTURE CLOSURE DEVICE | Mar 1, 1994 | Substantially Equivalent |
| K932540 | LAPORASCOPIC SURGICAL INSTRUMENTS /GENERAL USE | Feb 17, 1994 | Substantially Equivalent |
| K940193 | SURGICAL RETRACTOR KIT | Feb 15, 1994 | Substantially Equivalent |
| K935878 | GLASSER SUTURE NEEDLE | Feb 9, 1994 | Substantially Equivalent |
| K933812 | ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES | Dec 13, 1993 | Substantially Equivalent |