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

Speculum, Vaginal, Metal, Fiberoptic

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

HDG is the FDA product code for Speculum, Vaginal, Metal, Fiberoptic, 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 no recalls.

Classification record

Product code
HDG
Device name
Speculum, Vaginal, Metal, Fiberoptic
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
0

Clearances, product code HDG

By decision year
2 clearances under product code HDG with a decision year between 1977 and 1987, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HDG by decision year
YearClearances
19771
19871

Applicants with the most clearances

Product code HDG
Applicants holding the most 510(k) clearances under product code HDG
ApplicantClearances
Luxtec Corp.1
Welch Allyn Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 19 companies shown, in name order