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FDA 510(k)

ROMBEAU GASTROSTOMY-JEJUNAL TUBE

K-Number: K822380 · 1982-09-17

ApplicantHedeco
Decision Date1982-09-17
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ROMBEAU GASTROSTOMY-JEJUNAL TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Hedeco. It received FDA 510(k) clearance on 1982-09-17 under 510(k) number K822380. 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 ROMBEAU GASTROSTOMY-JEJUNAL TUBE?

ROMBEAU GASTROSTOMY-JEJUNAL TUBE is a medical device that received FDA 510(k) clearance on 1982-09-17. The listed applicant is Hedeco. The 510(k) number is K822380.

When did ROMBEAU GASTROSTOMY-JEJUNAL TUBE receive FDA 510(k) clearance?

ROMBEAU GASTROSTOMY-JEJUNAL TUBE received FDA 510(k) clearance on 1982-09-17, under 510(k) number K822380.

Who is the listed applicant for ROMBEAU GASTROSTOMY-JEJUNAL TUBE?

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

What is the FDA product code for ROMBEAU GASTROSTOMY-JEJUNAL TUBE?

The FDA product code for ROMBEAU GASTROSTOMY-JEJUNAL TUBE 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 Hedeco 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.

K830497PEM-TK820063KEOFEED 500 ENTERIC FEEDING PUMPK812507THE KEOFEED STOMACH TUBE

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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