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Mini-Coner

by Medical Testing System, Inc.

510(k) K770641

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 NumberK770641 Date24 Jun 1977ClearedStatusActive

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  • Withdrawn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
Mini-Coner Tm
510(k) Number
FDA Product Code
KNA
Device Class
Class II
Regulation
21 CFR Part 884.4530
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

The Mini-Coner is a Manual, Specialized Obstetric-Gynecologic Instrument, designed for the collection of gynecological specimens. Classified as a Class II device under FDA regulation 884.4530, it is intended for use in obstetrics and gynecology procedures requiring precise specimen retrieval.

This device is supplied as a reusable instrument, intended for clinical use in sterile conditions. It is regulated under the FDA’s 510(k) clearance (K770641) with a decision of Substantially Equivalent (SESE) and falls under product code KNA. No MRI safety or single-use specifications are noted in the regulatory data.

Other devices from Medical Testing System, Inc.

Questions

AI-generated answers, 19 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 Mini-Coner™ primarily used for in clinical settings?

    The Mini-Coner™ is a manual, specialized obstetric-gynecologic instrument designed specifically for the precise collection of gynecological specimens during obstetrics and gynecology procedures. Its purpose is to aid in retrieving samples for diagnostic or procedural purposes in sterile clinical environments.

  • Is the Mini-Coner™ intended for single-use or reusable applications?

    The Mini-Coner™ is supplied as a reusable instrument, meaning it is intended to be sterilized and reused in clinical settings. It is explicitly noted for use in sterile conditions, so proper cleaning and sterilization protocols must be followed between uses.

  • What regulatory pathway was followed for the FDA clearance of the Mini-Coner™?

    The Mini-Coner™ received FDA clearance through a 510(k) submission (K770641) with a decision of Substantially Equivalent (SESE). The device falls under product code KNA and was reviewed by the Obstetrics/Gynecology (OB) advisory committee, indicating its classification as a Class II device under FDA regulation 884.4530.

  • Are there multiple sizes or models of the Mini-Coner™ available?

    The regulatory data lists multiple FEI (Final Establishment Identification) numbers associated with the Mini-Coner™, which suggests there may be variations or models produced under this device name. However, specific size or model details (e.g., dimensions, configurations) are not provided in the available data.

  • Does the Mini-Coner™ have any special considerations for storage or handling?

    While the data does not specify storage conditions explicitly, the Mini-Coner™ is a reusable instrument intended for sterile use. Proper storage should ensure it remains clean, protected from contamination, and ready for sterilization before reuse. Follow manufacturer guidelines for cleaning and sterilization to maintain its integrity and functionality.