Laparoscope, General & Plastic Surgery 510(k) Clearances

Product code GCJ is the FDA classification for Laparoscope, General & Plastic Surgery, a Class 2 device regulated under 21 CFR 876.1500, reviewed by the FDA Gastroenterology, Urology panel. FDA has cleared 1,426 510(k) submissions under this product code.

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).

Devices under product code GCJshare an FDA classification category, but product-code overlap does not establish the same intended use, technological characteristics, or legal predicate eligibility. Treat this list as a screening cohort and review each device's indications, labeling, substantial-equivalence summary, and current legal-marketing status.