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INSEMI-CATH

by Cook Ob/Gyn

510(k) K931630

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK931630 Date19 Apr 1994ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MFD
Device Class
Class II
Regulation
21 CFR Part 884.5250
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

INSEMI-CATH is a cannula for intrauterine insemination, classified as a Class 2 device in the Obstetrics/Gynecology specialty. It is designed for the introduction of washed spermatozoa into the uterine cavity.

The device features a flared proximal end to affix to a standard Luer slip syringe and is made from nontoxic materials. It is supplied in boxes of 20 and was cleared via the FDA 510(k) pathway under K931630 on April 19, 1994, with traditional review.

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Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the INSEMI-CATH used for?

    The INSEMI-CATH is designed for the introduction of washed spermatozoa into the uterine cavity during intrauterine insemination procedures.

  • How is the INSEMI-CATH supplied and packaged?

    The device is supplied in boxes of 20 units, with a flared proximal end designed to affix to a standard Luer slip syringe for use in clinical settings.

  • Is the INSEMI-CATH intended for single-use or reuse?

    Based on its classification as a Class 2 device and typical use in intrauterine insemination, the INSEMI-CATH is intended for single-use to prevent cross-contamination and ensure patient safety.