510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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HDLClass I

Retractor, Vaginal

21 CFR 884.4520 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

HDL is the FDA product code for Retractor, Vaginal, a class I device type, regulated under 21 CFR 884.4520. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
HDL
Device name
Retractor, Vaginal
Regulation
21 CFR 884.4520
Device class
Class I
Review panel
Obstetrics/Gynecology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
1

Clearances, product code HDL

By decision year
2 clearances under product code HDL with a decision year between 1978 and 1989, 1978 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HDL by decision year
YearClearances
19781
19891

Applicants with the most clearances

Product code HDL
Applicants holding the most 510(k) clearances under product code HDL
ApplicantClearances
Edward Weck, Inc.1
Zinnanti Surgical Instruments, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 117 companies shown, in name order