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FDA 510(k)

LEESPEC DISPOSABLE VAGINAL SPECULUM

K-Number: K021017 · 2002-06-19

ApplicantItl Corporation Pty, Ltd.
Decision Date2002-06-19
Product CodeHIB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LEESPEC DISPOSABLE VAGINAL SPECULUM is the device name listed in this FDA 510(k) record. The listed applicant is Itl Corporation Pty, Ltd.. It received FDA 510(k) clearance on 2002-06-19 under 510(k) number K021017. 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 LEESPEC DISPOSABLE VAGINAL SPECULUM?

LEESPEC DISPOSABLE VAGINAL SPECULUM is a medical device that received FDA 510(k) clearance on 2002-06-19. The listed applicant is Itl Corporation Pty, Ltd.. The 510(k) number is K021017.

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

LEESPEC DISPOSABLE VAGINAL SPECULUM received FDA 510(k) clearance on 2002-06-19, under 510(k) number K021017.

Who is the listed applicant for LEESPEC DISPOSABLE VAGINAL SPECULUM?

The FDA 510(k) record lists Itl Corporation Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for LEESPEC 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.

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Other records listing Itl Corporation Pty, Ltd. 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.

K153472Quiver Laparoscopic ExtendableK021941SAMPLOK LUER KITK000777SAMPLOKK991404PLATYPUS AV FISTULA NEEDLE PROTECTOR (AVFNP)

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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