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FDA 510(k)

COMPAT MINI-G REPLACEMENT GASTROSTOMY TUBE

K-Number: K981323 · 1998-10-09

ApplicantNovartis Nutrition Corp.
Decision Date1998-10-09
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COMPAT MINI-G REPLACEMENT GASTROSTOMY TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Novartis Nutrition Corp.. It received FDA 510(k) clearance on 1998-10-09 under 510(k) number K981323. 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 COMPAT MINI-G REPLACEMENT GASTROSTOMY TUBE?

COMPAT MINI-G REPLACEMENT GASTROSTOMY TUBE is a medical device that received FDA 510(k) clearance on 1998-10-09. The listed applicant is Novartis Nutrition Corp.. The 510(k) number is K981323.

When did COMPAT MINI-G REPLACEMENT GASTROSTOMY TUBE receive FDA 510(k) clearance?

COMPAT MINI-G REPLACEMENT GASTROSTOMY TUBE received FDA 510(k) clearance on 1998-10-09, under 510(k) number K981323.

Who is the listed applicant for COMPAT MINI-G REPLACEMENT GASTROSTOMY TUBE?

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

What is the FDA product code for COMPAT MINI-G REPLACEMENT GASTROSTOMY TUBE?

The FDA product code for COMPAT MINI-G REPLACEMENT GASTROSTOMY TUBE is KNT.

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Other records listing Novartis Nutrition Corp. 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.

K080340COMPAT DUALFLO ENTERAL DELIVERY PUMP SET WITH SPIKERIGHT PIERCING SPIKE AND 1000 ML WAER BAGK071191NOVARTIS COMPAT SURGICAL GASTROSTOMY JEJUNOSTOMY FEEDING TUBE KITK001916COMPAT REPLACEMENT GASTROSTOMY TUBE KIT, MODEL 0974XXK991668COMPAT JEJUNOSTOMY TUBE KIT, MODEL 088OXX (XX=16,14, OR 12)

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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