510(k) K152802
K152802 is an FDA 510(k) premarket notification submitted by Micro-Tech (Nanjing) Co., Ltd. for the device "Grasping Forceps". The FDA issued a decision of Substantially Equivalent on January 21, 2016. The device falls under product code OCZ (Endoscopic Grasping/Cutting Instrument, Non-Powered), a Class II device regulated under 21 CFR 876.1500. Micro-Tech (Nanjing) Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 21, 2016
- Date Received
- September 28, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscopic Grasping/Cutting Instrument, Non-Powered
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
To manually grasp stones, tissues or other objects through an endoscope. To manipulate, sample or cut tissues through an endoscope.