DeviceClearance

Product code HDA— Obstetrics/Gynecology

AUTO SUTURE(R) ENDOSCOPIC CLAMP

Classification name
Forceps, Obstetrical
Device class
Class 2
Regulation
21 CFR 884.4400
Advisory panel
Obstetrics/Gynecology
Total cleared
10
First cleared
Most recent

Market context for product code HDA

FDA has cleared 10 devices under product code HDA between 1977 and 2010, filed by 10 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

Top applicants under product code HDA

Recent clearances under product code HDA

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