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) (K242901)
Description
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) by Tools For Surgery, LLC, an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242901
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. 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) (K242901) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K234145 | ViSiGi 3D Gastric Sizing Tube | Boehringer Laboratories | 2024 |
| K220218 | Siren SGT | Tools For Surgery, LLC | 2022 |
Trace the full predicate network for K242901
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.