About This 510(k) Submission
K242901 is an FDA 510(k) clearance for the ZZIREN? Orogastric Tube; ZZIREN? SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN? SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN? SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN? GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN? GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN? GBT Orogastric Tube - 40 Fr (ZZ-GBT-40), a Tubes, Gastrointestinal (and Accessories) (Class II — Special Controls, product code KNT), submitted by Tools For Surgery, LLC (East Setauket, US). The FDA issued a Cleared decision on January 10, 2025, 109 days after receiving the submission on September 23, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.