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Scintillant Dual Bent Tip Surgical Light, Scintillant Dual Straight Tip Surgical Light

by Engineered Medical Solutions Co., LLC

510(k) K133425

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 · Special NumberK133425 Date5 Dec 2013ClearedStatusActive

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  • Withdrawn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
FTD
Device Class
Class II
Regulation
21 CFR Part 878.4580
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 Scintillant Dual Bent Tip Surgical Light and Scintillant Dual Straight Tip Surgical Light are sterile, single-use, battery-powered devices designed to provide localized white illumination of surgical sites. These devices feature dual light tips on flexible leads containing memory wire, allowing surgeons to direct light from multiple angles to optimize visibility. They are offered in two models, the Straight Tip and the Bent Tip, each with two individual 20-inch long wands with an LED at the tip.

The devices are supplied as sterile, single-use items and are battery-powered. They are intended for use in surgical settings to illuminate specific areas, such as spinal retractor blades. The non-tethered design enables easy maneuverability. The device is regulated under FDA 510(k) clearance (K133425) and is classified as a Class II medical device.

Other devices from Engineered Medical Solutions Co., LLC

Questions

AI-generated answers, 26 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 Scintillant Dual Surgical Light used for?

    It is a sterile, battery-powered device designed to provide localized white illumination of surgical sites, such as spinal retractor blades, to optimize visibility for the surgeon.

  • How is the device supplied and is it reusable?

    The device is supplied as a sterile, single-use item. It is not intended for reuse and should be discarded after a single procedure.

  • What are the differences between the Straight Tip and Bent Tip models?

    Both models are battery-powered and feature dual 20-inch LED wands with memory wire. The primary difference is the shape of the light tip: the Straight Tip has a straight end, while the Bent Tip has a bent end to facilitate different angles of illumination.

  • How does the device achieve maneuverability during surgery?

    The device features flexible leads containing memory wire, allowing the surgeon to direct the light from multiple angles. Its non-tethered design enables easy maneuverability to focus on specific areas.

  • What is the regulatory status of this device?

    The device is regulated under FDA 510(k) clearance (K133425) and is classified as a Class II medical device.