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Mednova Safety Bag

by Mednova Corp.

510(k) K853075

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 NumberK853075 Date16 Oct 1985ClearedStatusActive

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  • Withdrawn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
LHI
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
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.

The Mednova Safety Bag is a medical device identified by the device name MEDNOVA SAFETY BAG and product code LHI. It received FDA 510(k) clearance under K853075, with a decision of substantially equivalent, and is classified under the advisory committee description General Hospital (HO).

The device was cleared via a traditional 510(k) pathway, with the application received on July 23, 1985, and a decision date of October 16, 1985. It is manufactured by Mednova Corp. at 655 Third Ave., New York, NY 10017. No information regarding sterility, single-use or reusable status, MRI safety, sizes, storage, or clinical indications is provided in the data.

Other devices from Mednova Corp.

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 Mednova Safety Bag used for?

    The device data does not specify clinical indications or intended use for the Mednova Safety Bag; only its identification, manufacturer, and regulatory clearance details are provided.

  • Is the Mednova Safety Bag sterile or single-use?

    The provided data does not include information about sterility, single-use, or reusable status for the Mednova Safety Bag.

  • What sizes or models are available for the Mednova Safety Bag?

    No details regarding sizes, models, or variations of the Mednova Safety Bag are included in the device data.

  • How should the Mednova Safety Bag be stored?

    Storage conditions for the Mednova Safety Bag are not specified in the available device information.

  • What regulatory pathway was used for the Mednova Safety Bag?

    The Mednova Safety Bag received FDA 510(k) clearance through a traditional pathway, with application received July 23, 1985, and decision made October 16, 1985, under K853075.