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Operating Room Needle Counter

by Sharp-Trap, Inc.

510(k) K923512

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 NumberK923512 Date23 Nov 1992ClearedStatusActive

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  • Withdrawn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
MMK
Device Class
Class II
Regulation
21 CFR Part 880.5570
Advisory Committee
General Hospital
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 Operating Room Needle Counter is a device designed to track and manage sharps, specifically needles, within surgical environments. It functions as a container for holding and counting used needles to ensure safety, prevent loss, and maintain inventory control during surgical procedures.

This device is intended for single-use in operating rooms and is classified as a Class II medical device under FDA regulations. It is supplied as a reusable container for tracking sharps, with no indication of MRI compatibility or sterility requirements beyond standard surgical practice. The device holds multiple needle types and is authorized under FDA 510(k) clearance (K923512) for use in general hospital settings.

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 Operating Room Needle Counter designed for?

    The Operating Room Needle Counter is specifically designed to track and manage sharps, particularly needles, within surgical environments. It serves as a container for holding used needles, helping to ensure safety by preventing loss, reducing the risk of accidental sticks, and maintaining accurate inventory control during surgical procedures.

  • Is the device reusable or single-use?

    The Operating Room Needle Counter is supplied as a reusable container. While it is intended for single-use in tracking sharps during a surgical procedure, the container itself is designed to be reused across multiple procedures, provided it is cleaned and maintained properly.

  • Does the device require any special sterility measures beyond standard surgical practice?

    No, the device does not specify additional sterility requirements beyond those typically followed in standard surgical practice. It is intended for use in general hospital settings where existing protocols for cleanliness and infection control are already in place.

  • What types of needles can the device hold?

    The Operating Room Needle Counter is designed to hold multiple types of needles commonly used in surgical environments. While the exact specifications for needle sizes or types are not detailed in the description, its purpose is to accommodate standard sharps encountered in operating rooms.

  • How is the device authorized for use?

    The Operating Room Needle Counter is authorized under FDA 510(k) clearance with the clearance number K923512. It is classified as a Class II medical device and is intended for use in general hospital settings, as indicated by its regulatory submission.