Product code NWU— Gastroenterology, Urology

“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 kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.”

FDA has cleared 3 devices under product code NWU between 1981 and 1994, filed by 3 applicant companies. 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.

• 19941 clearance
• 19871 clearance
• 19811 clearance

• Inmed Corp.1 clearance
• Candela Laser Corp.1 clearance
• American Pharmaseal Div. Ahsc1 clearance

• K933268 — CANDELA GUIDEWIRECandela Laser Corp.·1994-02-10
• K874045 — PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWERAmerican Pharmaseal Div. Ahsc·1987-12-03
• K813332 — BRISTOL BALLON INTRODUCER, MANDRIL SETInmed Corp.·1981-12-14