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FDA 510(k)

GENESIS INSUFFLATING CATHETER

K-Number: K903669 · 1990-09-12

ApplicantGeneral Medical Co.
Decision Date1990-09-12
Product CodeBSY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

GENESIS INSUFFLATING CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is General Medical Co.. It received FDA 510(k) clearance on 1990-09-12 under 510(k) number K903669. The device is classified under product code BSY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENESIS INSUFFLATING CATHETER?

GENESIS INSUFFLATING CATHETER is a medical device that received FDA 510(k) clearance on 1990-09-12. The listed applicant is General Medical Co.. The 510(k) number is K903669.

When did GENESIS INSUFFLATING CATHETER receive FDA 510(k) clearance?

GENESIS INSUFFLATING CATHETER received FDA 510(k) clearance on 1990-09-12, under 510(k) number K903669.

Who is the listed applicant for GENESIS INSUFFLATING CATHETER?

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

What is the FDA product code for GENESIS INSUFFLATING CATHETER?

The FDA product code for GENESIS INSUFFLATING CATHETER is BSY.

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Other records listing General 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.

K926269PROCEDURE KITK912975OPERAND LUBRICATING JELLYK912132OPERAND LUBRICATING JELLYK900110OPERAND* LUBRICATING JELLYK853635SUBDERM TMK844652C.A.S.E. CONTAINER

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Related Devices (Code: BSY)

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.

K031997MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEMMallinckrodt Dar S.R.L.K992902AMBU HAND POWER SUCTION PUMPAmbu, Inc.K982945DUAL PURPOSE CLOSED CATHETERSpirit Medical Systems, Inc.K981910SUCTION CATHETERNi-Med, Inc.K972258HI-CARE CLOSED SUCTION SYSTEMMallinckrodt MedicalK973199AMSINO SUCTION CATHETERAmsino Intl., 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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