Vaginal Port, Non-Sterile / 600065, Vaginal Port, Sterile / 600073

by Sterinc

510(k) K002912

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K002912↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK002912	Date21 Feb 2001Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K002912
FDA Product Code: HIB

Device Class: Class II
Regulation: 21 CFR Part 884.4530
Advisory Committee: Obstetrics/Gynecology
FDA Decision: SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

A vaginal port is a speculum-type device used in obstetrics and gynecology procedures. It is designed for vaginal access during clinical examinations or interventions.

The device is supplied in both non-sterile and sterile configurations, with model numbers 600065 and 600073 respectively. It is classified as a Class II medical device under FDA regulation 884.4530 and received traditional 510(k) clearance (K002912) on February 21, 2001, based on substantial equivalence to a predicate device.