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FDA 510(k)

DUAL LUMEN TRANSCERIVICAL INTRAUTERINE KIT

K-Number: K920044 · 1992-04-03

ApplicantTelos Medical Corp.
Decision Date1992-04-03
Product CodeKXO
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

DUAL LUMEN TRANSCERIVICAL INTRAUTERINE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Telos Medical Corp.. It received FDA 510(k) clearance on 1992-04-03 under 510(k) number K920044. The device is classified under product code KXO. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUAL LUMEN TRANSCERIVICAL INTRAUTERINE KIT?

DUAL LUMEN TRANSCERIVICAL INTRAUTERINE KIT is a medical device that received FDA 510(k) clearance on 1992-04-03. The listed applicant is Telos Medical Corp.. The 510(k) number is K920044.

When did DUAL LUMEN TRANSCERIVICAL INTRAUTERINE KIT receive FDA 510(k) clearance?

DUAL LUMEN TRANSCERIVICAL INTRAUTERINE KIT received FDA 510(k) clearance on 1992-04-03, under 510(k) number K920044.

Who is the listed applicant for DUAL LUMEN TRANSCERIVICAL INTRAUTERINE KIT?

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

What is the FDA product code for DUAL LUMEN TRANSCERIVICAL INTRAUTERINE KIT?

The FDA product code for DUAL LUMEN TRANSCERIVICAL INTRAUTERINE KIT is KXO.

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Other records listing Telos Medical Corp. 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.

K920375DISPOSABLE INTRAUTERINE PRESSURE TRANSDUCERK914387TRANSCERVICAL INTRAUTERINE KITK905018LAB-SITE SAFETY NEEDLEK905017LAB-SITEK882224ULTRANS DISPOSABLE INTRAUTERINEK883832CATHETER, INTRAUTERINE AND INTRODUCER

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Related Devices (Code: KXO)

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.

K991235SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC)Ludlow Technical ProductsK982565EASY TRANS TIPCarl SchuhK974730SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC)Graphic Controls Corp.K964279SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC)Graphic Controls Corp.K961290IUP - TIP TRANS, IUP - PROXI TRANSScientific Device Manufacturer, LLCK950498LIFE TRACE TRANS TIP INTRAUTERINE PRESSURE CATHETERGraphic Controls Corp.

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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