FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Specimen Bag, model: WEP040306B, WEP010304B, WEP040304B, WEP010759B, WEP010709B, WEP010304A, WEP010759A, WEP010709A
K Number: K222828
·
Decision Mar 20, 2023
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
6
Review Days
182
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Basic Information
- Device Name
- Specimen Bag, model: WEP040306B, WEP010304B, WEP040304B, WEP010759B, WEP010709B, WEP010304A, WEP010759A, WEP010709A
- K Number
- K222828
- 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
- September 19, 2022
- Decision Date
- March 20, 2023
- 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 Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd
| K Number | Device Name | ||
|---|---|---|---|
| K241022 | Sterile single use tip cleaner (WK800-S10 , WK800-S20) | Jul 11, 2024 | Substantially Equivalent |
| K172578 | Equipment Pouch | Dec 7, 2017 | Substantially Equivalent |
| K172794 | Suction Irrigation Set | Nov 29, 2017 | Substantially Equivalent |
| K172038 | Trocar | Oct 27, 2017 | Substantially Equivalent |
| K172120 | Veress Needle | Sep 14, 2017 | Substantially Equivalent |