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FDA 510(k)

KENTEX DISPOSABLE VAGINAL SPECULUM

K-Number: K030693 · 2003-08-27

ApplicantKentron Health Care, Inc.
Decision Date2003-08-27
Product CodeHIB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

KENTEX DISPOSABLE VAGINAL SPECULUM is the device name listed in this FDA 510(k) record. The listed applicant is Kentron Health Care, Inc.. It received FDA 510(k) clearance on 2003-08-27 under 510(k) number K030693. The device is classified under product code HIB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KENTEX DISPOSABLE VAGINAL SPECULUM?

KENTEX DISPOSABLE VAGINAL SPECULUM is a medical device that received FDA 510(k) clearance on 2003-08-27. The listed applicant is Kentron Health Care, Inc.. The 510(k) number is K030693.

When did KENTEX DISPOSABLE VAGINAL SPECULUM receive FDA 510(k) clearance?

KENTEX DISPOSABLE VAGINAL SPECULUM received FDA 510(k) clearance on 2003-08-27, under 510(k) number K030693.

Who is the listed applicant for KENTEX DISPOSABLE VAGINAL SPECULUM?

The FDA 510(k) record lists Kentron Health Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KENTEX DISPOSABLE VAGINAL SPECULUM?

The FDA product code for KENTEX DISPOSABLE VAGINAL SPECULUM is HIB.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Kentron Health Care, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K972410IMPERVIOUS ISOLATION GOWNK971917KENTRON'S ISOLATION GOWNK953465KENTEMPK953914KENTEXK953830KENSORB

Related Devices (Code: HIB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252208JFord Speculum Sleeve™Ford Medtech, LLCK130046CLEARSPEC SINGLE USE VAGINAL SPECULUMClearspec, LLCK120743SPECULUM, VAGINAL, NONMETALWelch Allyn, Inc.K110766KOLPLUX SYSTEMKolplast CI LtdaK092870NON-STERILE DISPOSABLE VAGINAL SPECULUMKunshan Deyi Plastic Co., Ltd.K091937OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUMObp Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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