510(k) K962702
K962702 is an FDA 510(k) premarket notification submitted by General Surgical Innovations for the device "SPACEMAKER SERIAL SURGICAL BALLOON DISSECTOR, WITH CANNULA, WITH VISUALIZATION AND WITH VISUALIZATION AND CANNULA". The FDA issued a decision of Substantially Equivalent on February 19, 1997. The device falls under product code GCJ (Laparoscope, General & Plastic Surgery), a Class II device regulated under 21 CFR 876.1500. General Surgical Innovations has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 19, 1997
- Date Received
- July 12, 1996
- 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).