← FDA Medical Device Classifications
Endoscopic Grasping/Cutting Instrument, Non-Powered
OCZ · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.1500
Classification
- FDA Product Code
OCZ- 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
To manually grasp stones, tissues or other objects through an endoscope. To manipulate, sample or cut tissues through an endoscope.
Market data
- Cleared 510(k) submissions
- 73
- Registered establishments
- 48
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown