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FDA 510(k)

ULTRANS DISPOSABLE INTRAUTERINE

K-Number: K882224 · 1989-10-12

ApplicantTelos Medical Corp.
Decision Date1989-10-12
Product CodeHFN
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ULTRANS DISPOSABLE INTRAUTERINE 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 1989-10-12 under 510(k) number K882224. The device is classified under product code HFN. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRANS DISPOSABLE INTRAUTERINE?

ULTRANS DISPOSABLE INTRAUTERINE is a medical device that received FDA 510(k) clearance on 1989-10-12. The listed applicant is Telos Medical Corp.. The 510(k) number is K882224.

When did ULTRANS DISPOSABLE INTRAUTERINE receive FDA 510(k) clearance?

ULTRANS DISPOSABLE INTRAUTERINE received FDA 510(k) clearance on 1989-10-12, under 510(k) number K882224.

Who is the listed applicant for ULTRANS DISPOSABLE INTRAUTERINE?

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 ULTRANS DISPOSABLE INTRAUTERINE?

The FDA product code for ULTRANS DISPOSABLE INTRAUTERINE is HFN.

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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 TRANSDUCERK920044DUAL LUMEN TRANSCERIVICAL INTRAUTERINE KITK914387TRANSCERVICAL INTRAUTERINE KITK905018LAB-SITE SAFETY NEEDLEK905017LAB-SITEK883832CATHETER, INTRAUTERINE AND INTRODUCER

View all 7 devices →

Related Devices (Code: HFN)

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.

K250897Koala Intrauterine Pressure Catheter (IPC-5000E)Clinical Innovations, LLCK974389KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETERClinical Innovations, Inc.K973746PRE-FILLED SYRINGE FOR KOALA IUPClinical Innovations, Inc.K961424INTRAN 500Utah Medical Products, Inc.K954955STORC INTRAUTERINE PRESSURE CATHETERClinical Innovations, Inc.K955443INTRAN PLUSUtah Medical Products, Inc.

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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