510(k) K232866
K232866 is an FDA 510(k) premarket notification submitted by Jiangsu Channel Medical Device Co., Ltd. for the device "Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars)". The FDA issued a decision of Substantially Equivalent on November 7, 2023. The device falls under product code GCJ (Laparoscope, General & Plastic Surgery), a Class II device regulated under 21 CFR 876.1500.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 7, 2023
- Date Received
- September 15, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laparoscope, General & Plastic Surgery
- Device Class
- Class II
- Regulation Number
- 876.1500
- 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).