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HIB

Speculum, Vaginal, Nonmetal

Product code
HIB
Device name
Speculum, Vaginal, Nonmetal
Device class
Class 2
21 CFR
21 CFR 884.4530
Medical specialty
Obstetrics/Gynecology
Marketing pathway
510(K) Exempt
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
72 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2026-03-06.

NumberDecision dateApplicantDevice nameSummary
K2522082026-03-06Ford Medtech, LLCJFord Speculum Sleeve™PDF

1 summaries are archived here for direct download.

Official FDA classification page: HIB
Classification and pathway per current FDA publications. Data from openFDA (CC0).