← FDA Medical Device Classifications
Endoscopic Injection Needle, Gastroenterology-Urology
FBK · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.1500
Classification
- FDA Product Code
FBK- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 876.1500
- Review panel
- GU
- Medical specialty
- Gastroenterology, Urology
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- Y
Definition
inserted through endoscope for injection of a solution, gas, or implantable materials into gi or gu tissue.
Market data
- Cleared 510(k) submissions
- 88
- Registered establishments
- 97
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown