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Visualization Insemination Catheter

by Medworks Corp.

510(k) K982630

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 NumberK982630 Date14 Jan 1999ClearedStatusActive

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  • Withdrawn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)

Full name
Medworks Visualization Insemination Catheter
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, 1 Oct 2026

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

The Visualization Insemination Catheter is a Cannula, Intrauterine Insemination device (product code MFD) designed for intrauterine insemination procedures. It features a malleable catheter with distal side ports and a lumen, allowing integration with a fiberoptic device to visualize the uterine interior. This visualization capability enables real-time confirmation of catheter tip placement within the uterine cavity, enhancing the precision of insemination fluid delivery compared to traditional blind techniques. The device is intended for use in obstetrics and gynecology settings.

This catheter is supplied as a single-use, sterile medical device and is classified under FDA Class II with Special Controls. It is intended for use by physicians during intrauterine insemination to improve accuracy through visual feedback. The device holds an FDA 510(k) clearance (K982630) and is regulated under the applicable FDA regulation number 884.5250. Storage and handling must comply with standard sterile medical device protocols.

Other devices from Medworks Corp.

Questions

AI-generated answers, 1 Oct 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 Medworks Visualization Insemination Catheter used for?

    This catheter is designed specifically for intrauterine insemination (IUI) procedures in obstetrics and gynecology. Its key feature is the ability to integrate with a fiberoptic device, allowing real-time visualization of the uterine cavity. This helps physicians confirm catheter tip placement before delivering insemination fluid, reducing the risk of misplacement compared to non-visualized techniques.

  • How is the Medworks Visualization Insemination Catheter supplied and what does this mean for clinical use?

    The device is supplied as a single-use, sterile catheter. This means each unit is intended for one procedure only and must be discarded after use to maintain sterility and prevent cross-contamination. Clinicians should follow standard sterile medical device protocols for storage, handling, and preparation to ensure safety and efficacy.

  • Is the catheter reusable or intended for single-use, and why does this matter?

    The Medworks Visualization Insemination Catheter is explicitly designed for single-use only. Single-use devices are engineered to be safe, sterile, and effective for one procedure, eliminating risks associated with reprocessing (e.g., contamination or damage). Reusing medical devices can compromise sterility and patient safety, which is why regulatory standards like FDA Class II require clear single-use labeling for such products.

  • What distinguishes this catheter from traditional intrauterine insemination catheters?

    Unlike conventional catheters, which rely on blind placement techniques, the Medworks Visualization Insemination Catheter includes a malleable design with distal side ports and a lumen compatible with fiberoptic imaging. This enables clinicians to visually confirm catheter tip positioning within the uterine cavity in real time, enhancing precision during insemination fluid delivery and potentially improving procedural outcomes.

  • How should the Medworks Visualization Insemination Catheter be stored to ensure sterility?

    The catheter must be stored according to standard sterile medical device protocols. This typically involves keeping it in its original, sealed packaging in a clean, dry environment protected from direct sunlight, extreme temperatures, or physical damage. Unopened sterile packaging should be stored at room temperature unless manufacturer-specific instructions (not provided here) dictate otherwise. Always check expiration dates and ensure the packaging remains intact before use.