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FDA 510(k)

LAPAROSCOPIC GASTROSTOMY KIT

K-Number: K973891 · 1998-01-12

ApplicantApplied Medical Resources
Decision Date1998-01-12
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LAPAROSCOPIC GASTROSTOMY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources. It received FDA 510(k) clearance on 1998-01-12 under 510(k) number K973891. 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 LAPAROSCOPIC GASTROSTOMY KIT?

LAPAROSCOPIC GASTROSTOMY KIT is a medical device that received FDA 510(k) clearance on 1998-01-12. The listed applicant is Applied Medical Resources. The 510(k) number is K973891.

When did LAPAROSCOPIC GASTROSTOMY KIT receive FDA 510(k) clearance?

LAPAROSCOPIC GASTROSTOMY KIT received FDA 510(k) clearance on 1998-01-12, under 510(k) number K973891.

Who is the listed applicant for LAPAROSCOPIC GASTROSTOMY KIT?

The FDA 510(k) record lists Applied Medical Resources as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LAPAROSCOPIC GASTROSTOMY KIT?

The FDA product code for LAPAROSCOPIC GASTROSTOMY KIT is KNT.

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Other records listing Applied Medical Resources as applicant

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K200021Applied Medical AnoscopeK162676Voyant Open Fusion DeviceK153017Voyant Fine FusionK153288Voyant Open Fusion DeviceK151480Epix Electrosurgical Probe with Smoke EvacuationK100959SPECIMEN RETRIEVAL SYSTEM

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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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