FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Endoscopic Injection Needle
K Number: K213239
·
Decision Jun 2, 2022
Classifications
1
FEI Numbers
98
Registration Numbers
98
Same Product Code
88
Applicant Total
6
Review Days
245
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Basic Information
- Device Name
- Endoscopic Injection Needle
- K Number
- K213239
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Beijing Zksk Technology Co., Ltd.
- Date Received
- September 30, 2021
- Decision Date
- June 2, 2022
- Product Code
- FBK
- 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 |
|---|---|---|---|
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Beijing Zksk Technology Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K242192 | Disposable Sphincterotome | Feb 6, 2025 | Substantially Equivalent |
| K231721 | Disposable Hot Biopsy Forceps | Dec 14, 2023 | Substantially Equivalent |
| K213217 | Disposable hemoclip | Nov 14, 2022 | Substantially Equivalent |
| K213222 | Disposable Polypectomy Snare | Jun 6, 2022 | Substantially Equivalent |
| K213223 | Multi-Band Ligator | Jun 6, 2022 | Substantially Equivalent |