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FDA 510(k)

NH REPLACEMENT GASTROSTOMY KIT

K-Number: K880232 · 1988-03-03

ApplicantBiosearch Medical Products, Inc.
Decision Date1988-03-03
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NH REPLACEMENT GASTROSTOMY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Biosearch Medical Products, Inc.. It received FDA 510(k) clearance on 1988-03-03 under 510(k) number K880232. 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 NH REPLACEMENT GASTROSTOMY KIT?

NH REPLACEMENT GASTROSTOMY KIT is a medical device that received FDA 510(k) clearance on 1988-03-03. The listed applicant is Biosearch Medical Products, Inc.. The 510(k) number is K880232.

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

NH REPLACEMENT GASTROSTOMY KIT received FDA 510(k) clearance on 1988-03-03, under 510(k) number K880232.

Who is the listed applicant for NH REPLACEMENT GASTROSTOMY KIT?

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

What is the FDA product code for NH REPLACEMENT GASTROSTOMY KIT?

The FDA product code for NH REPLACEMENT GASTROSTOMY KIT is KNT.

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Other records listing Biosearch Medical Products, 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.

K051480ENTERAL FEEDING TUBEK970145PERINEOMETER & VAGINAL PROBE (BIOFEEDBACK MONITOR #20 AND VAGINAL PROBE)K964871BIOSEARCH SYRING FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTSK951260URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANTK944614MEGA-BRUSH, ENDOSCOPIC MASS CYTOLOGY - CELLUAR RETRIEVAL SYSTEMK932295NON-BALLOON REPLACEMENT GASTROSTOMY KIT

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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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