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FDA 510(k)

PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TRAY

K-Number: K894939 · 1989-12-08

ApplicantNorth American Sterilization & Packaging Co.
Decision Date1989-12-08
Product CodeFPD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TRAY is the device name listed in this FDA 510(k) record. The listed applicant is North American Sterilization & Packaging Co.. It received FDA 510(k) clearance on 1989-12-08 under 510(k) number K894939. The device is classified under product code FPD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TRAY?

PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TRAY is a medical device that received FDA 510(k) clearance on 1989-12-08. The listed applicant is North American Sterilization & Packaging Co.. The 510(k) number is K894939.

When did PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TRAY receive FDA 510(k) clearance?

PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TRAY received FDA 510(k) clearance on 1989-12-08, under 510(k) number K894939.

Who is the listed applicant for PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TRAY?

The FDA 510(k) record lists North American Sterilization & Packaging Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TRAY?

The FDA product code for PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TRAY is FPD.

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Other records listing North American Sterilization & Packaging 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.

K964231NASP HYDROCOLLOID DRESSING (REGULAR OR THIN)K963753NASP TRANSPARENT DRESSINGK962352HYDROGEL SKIN DRESSINGK925588NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRIK925593NORTEC STERILE WATER FOR DEVICE IRRIGATIONK925161NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO

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Related Devices (Code: FPD)

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.

K243361NutrifitVygon USAK180236VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)Vr Medical Technology Co., Ltd.K131590INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBEPhilips Medical SystemsK120815INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBEPhilips Medical SystemsK121105NUTRISAFE 2 FEEDING TUBEVygon Corp.K100163NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXXVygon Corp.

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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