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Dr Japan Facil Point Spinal Needle

by Myco Medical, Inc.

510(k) K020934

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK020934 Date25 Oct 2002ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
BSP
Device Class
Class II
Regulation
21 CFR Part 868.5150
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

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

Dr Japan Facil Point Spinal Needle is a needle, conduction, anesthetic (with or without introducer) used for the spinal administration of anesthetic agents to provide regional anesthesia. It is a manual, non-powered device intended for use by healthcare professionals in clinical settings.

The device is supplied as a single-use, sterile product and is classified as a Class II medical device under FDA regulation number 868.5150. It received FDA 510(k) clearance (K020934) on October 25, 2002, and is substantially equivalent to a predicate device. The product is manufactured by Myco Medical, Inc. and is assigned product code BSP.

Other devices from Myco Medical, Inc.

Questions

AI-generated answers, 24 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 Dr Japan Facil Point Spinal Needle used for?

    The Dr Japan Facil Point Spinal Needle is used for the spinal administration of anesthetic agents to provide regional anesthesia. It is a conduction anesthetic needle, with or without an introducer, intended for use by healthcare professionals in clinical settings to deliver anesthetic agents into the subarachnoid space.

  • Is the Dr Japan Facil Point Spinal Needle sterile and single-use?

    Yes, the device is supplied as a single-use, sterile product. It is designed for one-time use only and must not be reused, as reusing could compromise sterility and patient safety. The sterile packaging ensures it is ready for immediate clinical use upon opening.

  • What regulatory pathway was used for the Dr Japan Facil Point Spinal Needle?

    The device received FDA 510(k) clearance (K020934) on October 25, 2002, and is classified as a Class II medical device under FDA regulation number 868.5150. It was determined to be substantially equivalent to a predicate device through the traditional 510(k) pathway.