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FDA 510(k)

GASPARAITIS ESOPHAGRAM CATHETER SET

K-Number: K911897 · 1991-07-24

ApplicantE-Z-Em, Inc.
Decision Date1991-07-24
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GASPARAITIS ESOPHAGRAM CATHETER SET is the device name listed in this FDA 510(k) record. The listed applicant is E-Z-Em, Inc.. It received FDA 510(k) clearance on 1991-07-24 under 510(k) number K911897. 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 GASPARAITIS ESOPHAGRAM CATHETER SET?

GASPARAITIS ESOPHAGRAM CATHETER SET is a medical device that received FDA 510(k) clearance on 1991-07-24. The listed applicant is E-Z-Em, Inc.. The 510(k) number is K911897.

When did GASPARAITIS ESOPHAGRAM CATHETER SET receive FDA 510(k) clearance?

GASPARAITIS ESOPHAGRAM CATHETER SET received FDA 510(k) clearance on 1991-07-24, under 510(k) number K911897.

Who is the listed applicant for GASPARAITIS ESOPHAGRAM CATHETER SET?

The FDA 510(k) record lists E-Z-Em, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GASPARAITIS ESOPHAGRAM CATHETER SET?

The FDA product code for GASPARAITIS ESOPHAGRAM CATHETER SET is KNT.

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Other records listing E-Z-Em, 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.

K071378MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIESK062449EMPOWERMR INJECTOR SYSTEM, MODEL 9730K063029EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900K053008E-Z-EM ENDOSCOPIC CO2 REGULATORK041178EMPOWER TRANSFER SET, (CAT. NO. 7725)K031571EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825

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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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