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FDA 510(k)

TRANSCERVICAL INTRAUTERINE KIT

K-Number: K914387 · 1991-12-30

ApplicantTelos Medical Corp.
Decision Date1991-12-30
Product CodeHGS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TRANSCERVICAL 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 1991-12-30 under 510(k) number K914387. The device is classified under product code HGS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRANSCERVICAL INTRAUTERINE KIT?

TRANSCERVICAL INTRAUTERINE KIT is a medical device that received FDA 510(k) clearance on 1991-12-30. The listed applicant is Telos Medical Corp.. The 510(k) number is K914387.

When did TRANSCERVICAL INTRAUTERINE KIT receive FDA 510(k) clearance?

TRANSCERVICAL INTRAUTERINE KIT received FDA 510(k) clearance on 1991-12-30, under 510(k) number K914387.

Who is the listed applicant for TRANSCERVICAL 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 TRANSCERVICAL INTRAUTERINE KIT?

The FDA product code for TRANSCERVICAL INTRAUTERINE KIT is HGS.

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

View all 7 devices →

Related Devices (Code: HGS)

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.

K905812INTRAUTERINE CATHETER SETEpcom Medical Systems, 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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