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FDA 510(k)

GAUDERER GASTROSTOMY BUTTON

K-Number: K843392 · 1984-10-11

ApplicantAmerican V. Mueller
Decision Date1984-10-11
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GAUDERER GASTROSTOMY BUTTON is the device name listed in this FDA 510(k) record. The listed applicant is American V. Mueller. It received FDA 510(k) clearance on 1984-10-11 under 510(k) number K843392. 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 GAUDERER GASTROSTOMY BUTTON?

GAUDERER GASTROSTOMY BUTTON is a medical device that received FDA 510(k) clearance on 1984-10-11. The listed applicant is American V. Mueller. The 510(k) number is K843392.

When did GAUDERER GASTROSTOMY BUTTON receive FDA 510(k) clearance?

GAUDERER GASTROSTOMY BUTTON received FDA 510(k) clearance on 1984-10-11, under 510(k) number K843392.

Who is the listed applicant for GAUDERER GASTROSTOMY BUTTON?

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

What is the FDA product code for GAUDERER GASTROSTOMY BUTTON?

The FDA product code for GAUDERER GASTROSTOMY BUTTON is KNT.

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Other records listing American V. Mueller 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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