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FDA 510(k)

GASTROSTOMY REPLACEMENT TUBE, MODEL 253

K-Number: K070124 · 2007-05-23

ApplicantDegania Silicone , Ltd.
Decision Date2007-05-23
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GASTROSTOMY REPLACEMENT TUBE, MODEL 253 is the device name listed in this FDA 510(k) record. The listed applicant is Degania Silicone , Ltd.. It received FDA 510(k) clearance on 2007-05-23 under 510(k) number K070124. 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 GASTROSTOMY REPLACEMENT TUBE, MODEL 253?

GASTROSTOMY REPLACEMENT TUBE, MODEL 253 is a medical device that received FDA 510(k) clearance on 2007-05-23. The listed applicant is Degania Silicone , Ltd.. The 510(k) number is K070124.

When did GASTROSTOMY REPLACEMENT TUBE, MODEL 253 receive FDA 510(k) clearance?

GASTROSTOMY REPLACEMENT TUBE, MODEL 253 received FDA 510(k) clearance on 2007-05-23, under 510(k) number K070124.

Who is the listed applicant for GASTROSTOMY REPLACEMENT TUBE, MODEL 253?

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

What is the FDA product code for GASTROSTOMY REPLACEMENT TUBE, MODEL 253?

The FDA product code for GASTROSTOMY REPLACEMENT TUBE, MODEL 253 is KNT.

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Other records listing Degania Silicone , Ltd. as applicant

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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

View on FDA Database →

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

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