Product code NXA— Anesthesiology

“This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.”

FDA has cleared 1 device under product code NXA, all in 1985, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• Washington-Greene County Branch Pennsylvania Assoc1 clearance

• K844051 — SKILCRAFT - TRACHEOTOMY CARE KIT 3 COMPARTMENTWashington-Greene County Branch Pennsylvania Assoc·1985-01-18