Product Code: GBQ FDA class 1 21 CFR 878.4200

Catheter, Continuous Irrigation

General, Plastic Surgery

The Catheter, Continuous Irrigation (product code GBQ) is a catheter designed to deliver a continuous flow of irrigating fluid into a wound, body cavity, or surgical site while simultaneously draining fluid, used during and after surgical procedures to keep the operative area clear. It is classified as FDA Class 1, posing minimal risk, subject only to general controls and not requiring premarket notification. The device is regulated under 21 CFR 878.4200 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.

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510(k)s

FEI Numbers

Registration Numbers

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Basic Information

Product Code: GBQ
Device Class: FDA class 1
Regulation Number: 878.4200
Medical Specialty: General, Plastic Surgery
Review Panel: SU
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 8 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K941356	MICROFLOW IRRIGATION SYSTEM	May 19, 1994	Substantially Equivalent	Jedmed Instrument Co.
K921464	CAT.#40100, 40102, 40104 & 40106 YANKAUER SUCT INT	May 05, 1992	Substantially Equivalent	Trinity Laboratories, Inc.
K882647	GESCO CATHETERIZATION TRAY	Sep 09, 1988	Unknown	Gesco Intl., Inc.
K874596	PERFORATED SOAKING TUBE	Dec 02, 1987	Substantially Equivalent	Specialty Medical Products Co.
K873097	PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR PLUS PAKS	Sep 04, 1987	Substantially Equivalent	Ipax, Inc.
K872787	MODIFIED CURLCATH	Aug 04, 1987	Substantially Equivalent	Quinton, Inc.
K791400	GASTRIC LAVAGE KIT-DISPOSABLE	Aug 16, 1979	Substantially Equivalent	Acumed Instruments Corp.
K771732	THORNTON ANTERIOR CHAMBER IRRIGATOR	Sep 28, 1977	Substantially Equivalent	Concept, Inc.