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FDA 510(k)

MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT

K-Number: K982894 · 1998-09-11

ApplicantBallard Medical Products
Decision Date1998-09-11
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Ballard Medical Products. It received FDA 510(k) clearance on 1998-09-11 under 510(k) number K982894. 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 MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT?

MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT is a medical device that received FDA 510(k) clearance on 1998-09-11. The listed applicant is Ballard Medical Products. The 510(k) number is K982894.

When did MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT receive FDA 510(k) clearance?

MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT received FDA 510(k) clearance on 1998-09-11, under 510(k) number K982894.

Who is the listed applicant for MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT?

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

What is the FDA product code for MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT?

The FDA product code for MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT is KNT.

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Other records listing Ballard Medical Products 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.

K030721QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLEK022398REUSABLE BRONCHIAL BIOPSY FORCEPSK013892LUTZ NEEDLEK000495BALLARD MEDICAL PRODUCTS EPIDURAL AND SPINAL NEEDLESK993138BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KITK990376BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME

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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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