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FDA 510(k)

PEG GUIDEWIRE SYSTEM GASTROSTOMY TUBE KIT

K-Number: K923983 · 1993-04-06

ApplicantSandoz Nutrition
Decision Date1993-04-06
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PEG GUIDEWIRE SYSTEM GASTROSTOMY TUBE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Sandoz Nutrition. It received FDA 510(k) clearance on 1993-04-06 under 510(k) number K923983. 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 PEG GUIDEWIRE SYSTEM GASTROSTOMY TUBE KIT?

PEG GUIDEWIRE SYSTEM GASTROSTOMY TUBE KIT is a medical device that received FDA 510(k) clearance on 1993-04-06. The listed applicant is Sandoz Nutrition. The 510(k) number is K923983.

When did PEG GUIDEWIRE SYSTEM GASTROSTOMY TUBE KIT receive FDA 510(k) clearance?

PEG GUIDEWIRE SYSTEM GASTROSTOMY TUBE KIT received FDA 510(k) clearance on 1993-04-06, under 510(k) number K923983.

Who is the listed applicant for PEG GUIDEWIRE SYSTEM GASTROSTOMY TUBE KIT?

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

What is the FDA product code for PEG GUIDEWIRE SYSTEM GASTROSTOMY TUBE KIT?

The FDA product code for PEG GUIDEWIRE SYSTEM GASTROSTOMY TUBE KIT is KNT.

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Other records listing Sandoz Nutrition 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.

K965087COMPAT GASTROSTOMY/JEJUNOSTOMY FEEDING TUBE KIT(088000)K961664COMPAT NASOJEJUNAL FEEDING TUBEK940555SANDOZ NUTRITION COMPAT ENTERAL FEED PUMP W/HYDRATIONK940556SANDOZ NUTRITION COMPAT(R) ENTERAL FEEDING PUMPK924308GASTROPORT IIK915308PEG GASTROSTOMY TUBE 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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