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FDA 510(k)

REPLACEMENT GASTROSTOMY TUBE

K-Number: K861323 · 1986-12-16

ApplicantMicrovasive
Decision Date1986-12-16
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

REPLACEMENT GASTROSTOMY TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Microvasive. It received FDA 510(k) clearance on 1986-12-16 under 510(k) number K861323. 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 REPLACEMENT GASTROSTOMY TUBE?

REPLACEMENT GASTROSTOMY TUBE is a medical device that received FDA 510(k) clearance on 1986-12-16. The listed applicant is Microvasive. The 510(k) number is K861323.

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

REPLACEMENT GASTROSTOMY TUBE received FDA 510(k) clearance on 1986-12-16, under 510(k) number K861323.

Who is the listed applicant for REPLACEMENT GASTROSTOMY TUBE?

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

What is the FDA product code for REPLACEMENT GASTROSTOMY TUBE?

The FDA product code for REPLACEMENT GASTROSTOMY TUBE is KNT.

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Other records listing Microvasive 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.

K872771LOW PROFILE GASTROSTOMYK870705THERMAL COAGULATORK861309JEJUNAL FEEDING TUBEK860366CHALLENGER HOT BIOPSY FORCEPSK860589INFLATOR/DEFLATOR PISTON SYRINGEK854238NEEDLE W/STYLET FOR IMPLANTATION

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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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