OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM— 510(k) K091937

Name: FDA 510(k) clearance K091937
Creator: U.S. Food and Drug Administration
Published: 2009-09-09

Substantially Equivalent

Obp Corporation

FDA 510(k) clearance K091937 for OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM, Substantially Equivalent on 2009-09-09. Applicant: Obp Corporation. Device class: 2.

Clearance details

Applicant: Obp Corporation
Product code: Code HIB
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2009-06-30
Decision date: 2009-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lawerence, MA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K091937

K-number listed on FDA's recall record

Z-2933-2026 — OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF: C020130-1Class II·Ongoing·OBP Medical Corporation·20260713

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K091937.

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