Product code HDL— Obstetrics/Gynecology

VAGINAL RETRACTOR

Classification name: Retractor, Vaginal
Device class: Class 1
Regulation: 21 CFR 884.4520
Advisory panel: Obstetrics/Gynecology
Total cleared: 2
First cleared: 1978-03-14
Most recent: 1989-03-17

Market context for product code HDL

FDA has cleared 2 devices under product code HDL between 1978 and 1989, filed by 2 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

19891 clearance
19781 clearance

Top applicants under product code HDL

Zinnanti Surgical Instruments, Inc.1 clearance
Edward Weck, Inc.1 clearance

Recent clearances under product code HDL

K891038 — VAGINAL RETRACTORS - KRISTELLER, DELEE, BREISKYZinnanti Surgical Instruments, Inc.·1989-03-17
K780349 — VAGINAL RETRACTOREdward Weck, Inc.·1978-03-14

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