DeviceClearance

Product code GCJ— Gastroenterology, Urology

MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER

Classification name
Laparoscope, General & Plastic Surgery
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
1,430
First cleared
Most recent

FDA classification definition

“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).”

— U.S. Food and Drug Administration, device classification record for product code GCJ under 21 CFR 876.1500, via openFDA

Market context for product code GCJ

FDA has cleared 1,430 devices under product code GCJ between 1977 and 2026, filed by 538 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code GCJ

Adverse events under product code GCJ

product code GCJ
Death
39
Injury
1,638
Malfunction
28,216
Other
11
Total
29,904

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code GCJ

1–100 of 1,430

Data sourced from openFDA. This site is unofficial and independent of the FDA.