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Office-Spec Disposable Side-Opening Speculum

FDA 510(k)

Class II (US FDA 510(k))

510(k) K091937

by Obp Corporation

Identifiers

510(k) Number
K091937 FDA 510(k)
FDA Product Code
HIB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 884.4530 FDA 510(k)
Regulation Number
884.4530 FDA 510(k)
Advisory Committee
Obstetrics/Gynecology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Office-Spec Disposable Side-Opening Speculum is a nonmetal vaginal speculum designed to provide access and exposure to the interior of the vagina and the exterior of the cervix. It utilizes opposing bi-valve plastic blades to separate the vaginal walls for procedures such as pelvic examinations or Pap smears.

This device is intended for single-use and is regulated under FDA 510(k) clearance. It features an integrated light source and a side-opening mechanism for blade adjustment.

Frequently asked questions

What is the intended use of the Office-Spec Disposable Side-Opening Speculum?

This device is designed to provide access and exposure to the interior of the vagina and the exterior of the cervix. It uses opposing bi-valve plastic blades to separate the vaginal walls for clinical procedures such as pelvic examinations or Pap smears.

Is this speculum intended for single-use or can it be reprocessed?

The Office-Spec is intended for single-use only. It is constructed from nonmetal materials and is not designed for the cleaning or sterilization cycles required for reuse.

Does the device include any specialized features for clinical use?

Yes, the device features an integrated light source to assist with visualization during examinations and a side-opening mechanism that allows for convenient blade adjustment.

What is the regulatory status of this device?

The Office-Spec Disposable Side-Opening Speculum is regulated under FDA 510(k) clearance, which indicates it has been found substantially equivalent to legally marketed predicate devices.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Office-spec Disposable Side-opening Speculum, PDF PL-02-0001-I 说明书 - coopersurgical.com, Lighted Specula Kits And Accessories - CooperSurgical

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Obp Corporation

Sources (1)

  • FDA 510(k) K091937 24 fields · synced Sep 25, 2026