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FDA 510(k)

RADIUS PULL PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT

K-Number: K972025 · 1998-01-23

ApplicantRadius Intl., Inc.
Decision Date1998-01-23
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RADIUS PULL PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Radius Intl., Inc.. It received FDA 510(k) clearance on 1998-01-23 under 510(k) number K972025. 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 RADIUS PULL PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT?

RADIUS PULL PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT is a medical device that received FDA 510(k) clearance on 1998-01-23. The listed applicant is Radius Intl., Inc.. The 510(k) number is K972025.

When did RADIUS PULL PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT receive FDA 510(k) clearance?

RADIUS PULL PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT received FDA 510(k) clearance on 1998-01-23, under 510(k) number K972025.

Who is the listed applicant for RADIUS PULL PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT?

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

What is the FDA product code for RADIUS PULL PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT?

The FDA product code for RADIUS PULL PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT 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 Radius Intl., 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.

K972102RADIUS PUSH OVER THE GUIDE WIRE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KITK971901RADIUS LOW PROFILE GASTROSTOMY TUBE KITK951560RADIUS MANUAL WHWWLCHAIRS (COBRA, VIPER, SWING, OLYMPIA, AND MOBIL MODELS)K930510RADIUS ENTERAL FEEDING 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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