510(k) K171825
K171825 is an FDA 510(k) premarket notification submitted by Hunan Handlike Minimally Invasive Surgery Co., Ltd. for the device "Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument". The FDA issued a decision of Substantially Equivalent on February 13, 2018. The device falls under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories), a Class II device regulated under 21 CFR 878.4400. Hunan Handlike Minimally Invasive Surgery Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 13, 2018
- Date Received
- June 19, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrosurgical, Cutting & Coagulation & Accessories
- Device Class
- Class II
- Regulation Number
- 878.4400
- Review Panel
- SU
- Submission Type
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).