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FDA 510(k)

ENTERA* ENTERAL FEEDING BAG

K-Number: K881162 · 1988-06-03

ApplicantSmash Ent., Inc.
Decision Date1988-06-03
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENTERA* ENTERAL FEEDING BAG is the device name listed in this FDA 510(k) record. The listed applicant is Smash Ent., Inc.. It received FDA 510(k) clearance on 1988-06-03 under 510(k) number K881162. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENTERA* ENTERAL FEEDING BAG?

ENTERA* ENTERAL FEEDING BAG is a medical device that received FDA 510(k) clearance on 1988-06-03. The listed applicant is Smash Ent., Inc.. The 510(k) number is K881162.

When did ENTERA* ENTERAL FEEDING BAG receive FDA 510(k) clearance?

ENTERA* ENTERAL FEEDING BAG received FDA 510(k) clearance on 1988-06-03, under 510(k) number K881162.

Who is the listed applicant for ENTERA* ENTERAL FEEDING BAG?

The FDA 510(k) record lists Smash Ent., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENTERA* ENTERAL FEEDING BAG?

The FDA product code for ENTERA* ENTERAL FEEDING BAG is KNT.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Smash Ent., Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K880857SYRINGE PUMP MS2000K880373IONOMETER E-HK AND ACCESSORIESK870183IONOMETER EF AND ACCESSORIES

Related Devices (Code: KNT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K26189052Fr ViSiGi LUX™; 52Fr ViSiGi 3D®Boehringer Laboratories, LLCK253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300)C.R. Bard, Inc.K250389XNY Disposable Gastric Calibration TubeChangzhou Xin Neng Yuan Medical Stapler Co.,LtdK243228Flexi-Seal AIR (with ENFit Connector)ConvatecK242336hygh-tec Drainage IIAmb MedtecK242901ZZIREN™ 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)Tools For Surgery, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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