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FDA 510(k)

ARGYLE MADEN SILICONE GASTROSTOMY TUBE

K-Number: K830794 · 1983-05-18

ApplicantSherwood Medical Co.
Decision Date1983-05-18
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ARGYLE MADEN SILICONE GASTROSTOMY TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Sherwood Medical Co.. It received FDA 510(k) clearance on 1983-05-18 under 510(k) number K830794. 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 ARGYLE MADEN SILICONE GASTROSTOMY TUBE?

ARGYLE MADEN SILICONE GASTROSTOMY TUBE is a medical device that received FDA 510(k) clearance on 1983-05-18. The listed applicant is Sherwood Medical Co.. The 510(k) number is K830794.

When did ARGYLE MADEN SILICONE GASTROSTOMY TUBE receive FDA 510(k) clearance?

ARGYLE MADEN SILICONE GASTROSTOMY TUBE received FDA 510(k) clearance on 1983-05-18, under 510(k) number K830794.

Who is the listed applicant for ARGYLE MADEN SILICONE GASTROSTOMY TUBE?

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

What is the FDA product code for ARGYLE MADEN SILICONE GASTROSTOMY TUBE?

The FDA product code for ARGYLE MADEN SILICONE GASTROSTOMY TUBE is KNT.

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Other records listing Sherwood Medical Co. 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.

K981365MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONSK960982MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULAK962880SENSI-TOUCH COMBO SPINAL/EPIDURAL REGIONAL ANESTHESIA DELIVERY SYSTEMK960574ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEMK960677KANGAROO JEJUNAL FEEDING SYSTEMK960632KANGAROO FEEDING TUBE PLACMENT STYLET

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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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