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FDA 510(k)

VAG O SPECULUM, MODELS VS1, VM1, VL1

K-Number: K042950 · 2004-11-30

ApplicantPanatrex, Inc.
Decision Date2004-11-30
Product CodeHIB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

VAG O SPECULUM, MODELS VS1, VM1, VL1 is the device name listed in this FDA 510(k) record. The listed applicant is Panatrex, Inc.. It received FDA 510(k) clearance on 2004-11-30 under 510(k) number K042950. 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 VAG O SPECULUM, MODELS VS1, VM1, VL1?

VAG O SPECULUM, MODELS VS1, VM1, VL1 is a medical device that received FDA 510(k) clearance on 2004-11-30. The listed applicant is Panatrex, Inc.. The 510(k) number is K042950.

When did VAG O SPECULUM, MODELS VS1, VM1, VL1 receive FDA 510(k) clearance?

VAG O SPECULUM, MODELS VS1, VM1, VL1 received FDA 510(k) clearance on 2004-11-30, under 510(k) number K042950.

Who is the listed applicant for VAG O SPECULUM, MODELS VS1, VM1, VL1?

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

What is the FDA product code for VAG O SPECULUM, MODELS VS1, VM1, VL1?

The FDA product code for VAG O SPECULUM, MODELS VS1, VM1, VL1 is HIB.

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Other records listing Panatrex, 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.

K982578QUANTI-TEST SYSTEM

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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