Defendo Disposable Air/Water Valve Model 100304

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K102409 ↗

FDA Product Code

ODC

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Endo Gator System

  Class II

  FDA 510(k) K031773 Active Cleared 24 Jun 2003

• Endogator Endoscopy Irrigation Pump, Model Egp-100

  Class II

  FDA 510(k) K060962 Active Cleared 19 Apr 2006

• Defendo (Tm) Biopsy Valve for Olympus(R) and Fujinon(R) Endoscopes, Model 100301, Defendo(Tm) Biopsy Valve for Pentax(R)

  Class II

  FDA 510(k) K090851 Active Cleared 2 Jul 2009

• Defendo Disposable Suction Valve Model 100305

  Class II

  FDA 510(k) K102581 Active Cleared 8 Nov 2010

• Endogater Avantage CO2 Insufflator

  Class II

  FDA 510(k) K113310 Active Cleared 20 Jun 2012

• Endo Smartcap

  Class II

  FDA 510(k) K093665 Active Cleared 15 Dec 2009

See all devices from Byrne Medical, Inc. →

• What specialties is the Defendo Disposable Air/Water Valve Model 100304 intended for use in, and why?

  The Defendo Disposable Air/Water Valve Model 100304 is designed for use in gastroenterology and urology procedures. This is explicitly stated in the advisory committee descriptions (Gastroenterology, Urology) and the medical specialty fields, which confirm its intended application areas for controlling air and water flow during endoscopic examinations in these specialties.

• Is the Defendo Disposable Air/Water Valve Model 100304 reusable or single-use, and what does this mean for clinical workflow?

  The device is single-use only, as clearly stated in the description. This means each valve is intended for one procedure, reducing the risk of cross-contamination and simplifying sterilization processes in clinical settings. Clinicians should discard it after use and open a new unit for subsequent procedures.

• How do I know if this valve is compatible with my endoscope, and what sizes or models are available?

  The Defendo Disposable Air/Water Valve Model 100304 is classified as an endoscope channel accessory, but the data provided does not specify exact sizes or model variations beyond the single model number (100304). Compatibility depends on your endoscope’s channel diameter and connection type—consult your endoscope manufacturer’s documentation or Byrne Medical for confirmation. The device is designed to fit standard endoscopic air/water ports.

• What regulatory pathway was followed for FDA clearance, and what does this mean for purchasing or clinical use?

  The Defendo Disposable Air/Water Valve Model 100304 underwent a traditional 510(k) clearance process (K102409) and is classified as a Class II device under product code ODC. This means it was determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets FDA safety and performance standards. Clinicians can trust its regulatory review, while purchasers should verify compatibility with their facility’s procurement policies for Class II devices.