FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Veress Needle
K Number: K172120
·
Decision Sep 14, 2017
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
14
Applicant Total
6
Review Days
63
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Basic Information
- Device Name
- Veress Needle
- K Number
- K172120
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd
- Date Received
- July 13, 2017
- Decision Date
- September 14, 2017
- 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.
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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ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEM
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FDA Class 2
·Gastroenterology, Urology
ACCESS EXPANSION SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ELMED PNEUMOPERITONEUM NEEDLES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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|---|---|---|---|
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| K172578 | Equipment Pouch | Dec 7, 2017 | Substantially Equivalent |
| K172794 | Suction Irrigation Set | Nov 29, 2017 | Substantially Equivalent |
| K172038 | Trocar | Oct 27, 2017 | Substantially Equivalent |