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Booty Endoscope Warmer

by T-Med, Inc. 510(k)

Active United States

510(k) K933515

Overview

The Booty Endoscope Warmer is a medical device designed to maintain the temperature of endoscopes during procedures, ensuring optimal conditions for use in gastroenterology and urology. It is classified as a laryngoscope and endoscope accessory, intended to prevent thermal stress on the device and improve patient comfort by warming the scope before insertion.

This device is supplied as a reusable medical instrument and is regulated under FDA 510(k) clearance (K933515) with a classification of Class II (GCI). It is intended for use in clinical settings where endoscopy procedures are performed, adhering to standard sterilization protocols for reusable medical devices. The device is not MRI-safe, and its specifications align with FDA regulation number 876.1500.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK933515 Date27 Oct 1993ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
GCI
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Questions

  • What is the Booty Endoscope Warmer used for?

    The Booty Endoscope Warmer is specifically designed to maintain and elevate the temperature of endoscopes before use in clinical procedures. This prevents thermal stress on the scope, which can occur during cold storage or transport, and enhances patient comfort by ensuring the scope is at a more physiological temperature when inserted. It is particularly useful in gastroenterology and urology settings where endoscopes are frequently used.

  • Is the Booty Endoscope Warmer a single-use or reusable device?

    The Booty Endoscope Warmer is a reusable medical instrument. As a reusable device, it must adhere to standard sterilization protocols to ensure safety and efficacy between uses. This classification aligns with FDA regulations for Class II devices and requires proper maintenance and cleaning procedures to prevent contamination or damage.

  • What regulatory approval does the Booty Endoscope Warmer hold?

    The Booty Endoscope Warmer has received FDA 510(k) clearance under the reference number K933515. This clearance confirms that the device is substantially equivalent to a legally marketed predicate device and meets the regulatory requirements for Class II medical devices under the FDA’s classification system. The device is also categorized under FDA regulation number 876.1500.

  • Can the Booty Endoscope Warmer be used with MRI equipment?

    No, the Booty Endoscope Warmer is not MRI-safe. If used in an MRI environment, the device could interfere with imaging or pose a risk to patients or staff. Always verify compatibility with MRI equipment before use in such settings.

  • What are the key specifications or features of the Booty Endoscope Warmer?

    The Booty Endoscope Warmer is designed as an accessory for laryngoscopes and endoscopes, focusing on maintaining optimal temperature for these devices. It is intended for clinical use in gastroenterology and urology procedures. The device’s specifications align with FDA guidelines for endoscope accessories, ensuring it meets performance and safety standards for thermal management during procedures.