FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEM
K Number: K960574
·
Decision Aug 5, 1996
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
14
Applicant Total
191
Review Days
175
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Basic Information
- Device Name
- ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEM
- K Number
- K960574
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sherwood Medical Co.
- Date Received
- February 12, 1996
- Decision Date
- August 5, 1996
- Product Code
- FHO
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FHO | Pneumoperitoneum Needle | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FHO), ordered by most recent decision date.
Veress Needle
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VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLE
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MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT
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PNEUMO-MATIC INSUFFLATION NEEDLE
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ACCESS EXPANSION SYSTEM
FDA 510(k)
FDA Class 2
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ELMED PNEUMOPERITONEUM NEEDLES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Sherwood Medical Co.
| K Number | Device Name | ||
|---|---|---|---|
| K981365 | MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONS | Nov 25, 1998 | Substantially Equivalent |
| K960982 | MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULA | Dec 23, 1996 | Substantially Equivalent |
| K962880 | SENSI-TOUCH COMBO SPINAL/EPIDURAL REGIONAL ANESTHESIA DELIVERY SYSTEM | Dec 9, 1996 | Unknown |
| K960677 | KANGAROO JEJUNAL FEEDING SYSTEM | May 13, 1996 | Substantially Equivalent |
| K960632 | KANGAROO FEEDING TUBE PLACMENT STYLET | May 9, 1996 | Substantially Equivalent |
| K955831 | ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM | Mar 28, 1996 | Substantially Equivalent |
| K954429 | KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KIT | Mar 8, 1996 | Unknown |
| K954525 | SENSI-TOUCH EPIDURAL ANESTHESIA FILTER | Jan 19, 1996 | Substantially Equivalent |
| K950201 | ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER | Dec 15, 1995 | Substantially Equivalent |
| K954300 | ARGYLE NEO-SERT HYDROPHILIC POLYURETHANE UMBILICAL VESSEL CATHETER INSERTION TRAY | Dec 13, 1995 | Substantially Equivalent |