IOB DISPOSABLE SPECULUM— 510(k) K132668

Substantially Equivalent

Iob Medical, Inc.

FDA 510(k) clearance K132668 for IOB DISPOSABLE SPECULUM, Substantially Equivalent on 2014-01-17. Applicant: Iob Medical, Inc.. Device class: 2.

Clearance details

Applicant: Iob Medical, Inc.
Product code: Code HIB
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2013-08-27
Decision date: 2014-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gaithersburg, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HIB

K252208 — JFord Speculum Sleeve2026-03-06
K133857 — BRELLA-SPEC(TM) VAGINAL SPECULUM2014-04-28
K130046 — CLEARSPEC SINGLE USE VAGINAL SPECULUM2013-08-06
K120743 — SPECULUM, VAGINAL, NONMETAL2012-03-23
K110766 — KOLPLUX SYSTEM2011-09-15

More clearances from Iob Medical, Inc.

K232638 — FilteredFlo Warming Blankets2023-10-24
K231596 — IOB Temperature Management System2023-06-30
K221669 — IOB Warming Blankets2022-12-27
K201896 — ivi N3003 Surgical face Mask, ivi N6006 Surgical mask2021-03-30
K190221 — IOB Warming Blankets2019-10-25

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