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FDA 510(k)

ENDOSCOPIC MANUAL AIR INSUFFLATOR

K-Number: K844689 · 1985-01-02

ApplicantJayco Pharmaceuticals
Decision Date1985-01-02
Product CodeFCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOSCOPIC MANUAL AIR INSUFFLATOR is the device name listed in this FDA 510(k) record. The listed applicant is Jayco Pharmaceuticals. It received FDA 510(k) clearance on 1985-01-02 under 510(k) number K844689. The device is classified under product code FCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOSCOPIC MANUAL AIR INSUFFLATOR?

ENDOSCOPIC MANUAL AIR INSUFFLATOR is a medical device that received FDA 510(k) clearance on 1985-01-02. The listed applicant is Jayco Pharmaceuticals. The 510(k) number is K844689.

When did ENDOSCOPIC MANUAL AIR INSUFFLATOR receive FDA 510(k) clearance?

ENDOSCOPIC MANUAL AIR INSUFFLATOR received FDA 510(k) clearance on 1985-01-02, under 510(k) number K844689.

Who is the listed applicant for ENDOSCOPIC MANUAL AIR INSUFFLATOR?

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

What is the FDA product code for ENDOSCOPIC MANUAL AIR INSUFFLATOR?

The FDA product code for ENDOSCOPIC MANUAL AIR INSUFFLATOR is FCX.

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Other records listing Jayco Pharmaceuticals 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.

K844690ENDOSCOPIC MULTIPLE BIOPSY INSTRUMENTK844691ENDOSCOPIC ASPIRATION CATHETER SETK842009ABDOMINAL PARACENTESIS TRAYK842001LIVER BIOPSY TRAYK841258FOREIGN BODY PROTECTORK840800POLYP-SAVER SLEVE

View all 9 devices →

Related Devices (Code: FCX)

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.

K262152VS-370CF, VS-370CTVISION MEDICAL Co., Ltd.K240847MedicCO2LON (MedicCO2LON)Ide Vision, Ltd.K230474EVA5 InsufflatorPalliare , Ltd.K202922END 200 Endoscopic TubesetPalliare , Ltd.K201096CO2mbiLEDKarl Storz Endoscopy America, Inc.K190985BAROnova Insufflation System, BAROnova Accessory KitBaronova, Inc.

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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