DeviceClearance

Product code HFX— Obstetrics/Gynecology

GOMCO CIRCUMCISION CLAMP

Classification name
Clamp, Circumcision
Device class
Class 2
Regulation
21 CFR 884.4530
Advisory panel
Obstetrics/Gynecology
Total cleared
27
First cleared
Most recent

Market context for product code HFX

FDA has cleared 27 devices under product code HFX between 1988 and 2026, filed by 25 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 HFX

Adverse events under product code HFX

product code HFX
Other
3
Total
3

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 HFX

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