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FDA 510(k)

VAGINAL PORT, NON-STERILE / 600065, VAGINAL PORT, STERILE / 600073

K-Number: K002912 · 2001-02-21

ApplicantSterinc
Decision Date2001-02-21
Product CodeHIB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

VAGINAL PORT, NON-STERILE / 600065, VAGINAL PORT, STERILE / 600073 is the device name listed in this FDA 510(k) record. The listed applicant is Sterinc. It received FDA 510(k) clearance on 2001-02-21 under 510(k) number K002912. 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 VAGINAL PORT, NON-STERILE / 600065, VAGINAL PORT, STERILE / 600073?

VAGINAL PORT, NON-STERILE / 600065, VAGINAL PORT, STERILE / 600073 is a medical device that received FDA 510(k) clearance on 2001-02-21. The listed applicant is Sterinc. The 510(k) number is K002912.

When did VAGINAL PORT, NON-STERILE / 600065, VAGINAL PORT, STERILE / 600073 receive FDA 510(k) clearance?

VAGINAL PORT, NON-STERILE / 600065, VAGINAL PORT, STERILE / 600073 received FDA 510(k) clearance on 2001-02-21, under 510(k) number K002912.

Who is the listed applicant for VAGINAL PORT, NON-STERILE / 600065, VAGINAL PORT, STERILE / 600073?

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

What is the FDA product code for VAGINAL PORT, NON-STERILE / 600065, VAGINAL PORT, STERILE / 600073?

The FDA product code for VAGINAL PORT, NON-STERILE / 600065, VAGINAL PORT, STERILE / 600073 is HIB.

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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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