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FDA 510(k)

MEDSCAND DISPOSABLE PLASTIC VAGINAL SPECULUM; EASY-SPEC PLASTIC VAGINAL SPECULUM, MODEL 303

K-Number: K984211 · 1998-12-23

ApplicantMedscand AB
Decision Date1998-12-23
Product CodeHIB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MEDSCAND DISPOSABLE PLASTIC VAGINAL SPECULUM; EASY-SPEC PLASTIC VAGINAL SPECULUM, MODEL 303 is the device name listed in this FDA 510(k) record. The listed applicant is Medscand AB. It received FDA 510(k) clearance on 1998-12-23 under 510(k) number K984211. 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 MEDSCAND DISPOSABLE PLASTIC VAGINAL SPECULUM; EASY-SPEC PLASTIC VAGINAL SPECULUM, MODEL 303?

MEDSCAND DISPOSABLE PLASTIC VAGINAL SPECULUM; EASY-SPEC PLASTIC VAGINAL SPECULUM, MODEL 303 is a medical device that received FDA 510(k) clearance on 1998-12-23. The listed applicant is Medscand AB. The 510(k) number is K984211.

When did MEDSCAND DISPOSABLE PLASTIC VAGINAL SPECULUM; EASY-SPEC PLASTIC VAGINAL SPECULUM, MODEL 303 receive FDA 510(k) clearance?

MEDSCAND DISPOSABLE PLASTIC VAGINAL SPECULUM; EASY-SPEC PLASTIC VAGINAL SPECULUM, MODEL 303 received FDA 510(k) clearance on 1998-12-23, under 510(k) number K984211.

Who is the listed applicant for MEDSCAND DISPOSABLE PLASTIC VAGINAL SPECULUM; EASY-SPEC PLASTIC VAGINAL SPECULUM, MODEL 303?

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

What is the FDA product code for MEDSCAND DISPOSABLE PLASTIC VAGINAL SPECULUM; EASY-SPEC PLASTIC VAGINAL SPECULUM, MODEL 303?

The FDA product code for MEDSCAND DISPOSABLE PLASTIC VAGINAL SPECULUM; EASY-SPEC PLASTIC VAGINAL SPECULUM, MODEL 303 is HIB.

Related Clinical Trials

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Other records listing Medscand AB 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.

K911432ACCELLON CERVICAL BIOSAMPLER

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

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

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