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FDA 510(k)

hygh-tec drainage

K-Number: K221400 · 2023-02-09

ApplicantCreative Balloons GmbH
Decision Date2023-02-09
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

hygh-tec drainage is the device name listed in this FDA 510(k) record. The listed applicant is Creative Balloons GmbH. It received FDA 510(k) clearance on 2023-02-09 under 510(k) number K221400. 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 hygh-tec drainage?

hygh-tec drainage is a medical device that received FDA 510(k) clearance on 2023-02-09. The listed applicant is Creative Balloons GmbH. The 510(k) number is K221400.

When did hygh-tec drainage receive FDA 510(k) clearance?

hygh-tec drainage received FDA 510(k) clearance on 2023-02-09, under 510(k) number K221400.

Who is the listed applicant for hygh-tec drainage?

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

What is the FDA product code for hygh-tec drainage?

The FDA product code for hygh-tec drainage is KNT.

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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