Product Code: GCY FDA class 1 21 CFR 878.4680

Apparatus, Suction, Single Patient Use, Portable, Nonpowered

General, Plastic Surgery

The Apparatus, Suction, Single Patient Use, Portable, Nonpowered (product code GCY) is a disposable, portable, and manually operated suction device used for a single patient to aspirate fluids, secretions, or debris without relying on an external power source, suitable for use in surgical or clinical settings. It is classified as FDA Class 1, the lowest risk level, subject only to general controls and not requiring premarket notification. The device is regulated under 21 CFR 878.4680 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.

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510(k)s

FEI Numbers

213

Registration Numbers

213

Unique Applicants

Years Active

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Basic Information

Product Code: GCY
Device Class: FDA class 1
Regulation Number: 878.4680
Medical Specialty: General, Plastic Surgery
Review Panel: SU
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 96 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K972703	REDYROB-CLOSED WOUND DRAINAGE SYSTEM	Oct 01, 1997	Substantially Equivalent	B.Braun Medical, Inc.
K971036	ODONTIT AUTOGENOUS BONE COLLECTION DEVICE	Jun 03, 1997	Substantially Equivalent	Interpore Intl.
K963839	CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500	Dec 12, 1996	Substantially Equivalent	Cordis Corp.
K960099	PENROSE DRAIN MODELS 6001 - 6007	Mar 11, 1996	Substantially Equivalent	Sil-Med Corp.
K950754	MACRO SUCTION TUBE MODEL NO 10061	Apr 25, 1995	Substantially Equivalent	Dlp, Inc.
K936223	PRESSURE IRRIGATING SYSTEM	May 12, 1994	Substantially Equivalent	Level 1 Technologies, Inc.
K930615	AUTOVAC CLOSED WOUND SUCTION SYSTEM	Feb 22, 1994	Substantially Equivalent	Boehringer Laboratories
K933319	BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION SYSTEM	Oct 27, 1993	Substantially Equivalent	Birtcher Medical Systems, Inc.
K933306	IMC 5.0MM IRRIGATION/ASPIRATION PROBE W/HOLES	Oct 05, 1993	Substantially Equivalent	Inman Medical Corp.
K933305	IMC 5.0MM IRRIGATION/ASPIRATION PROBE	Oct 05, 1993	Substantially Equivalent	Inman Medical Corp.
K933170	INMAN POOLE TIP SUCTION PROBE W/TUBING KIT	Sep 16, 1993	Substantially Equivalent	Inman Medical Corp.
K931950	POOLE TIP SUCTION PROBE	Aug 11, 1993	Substantially Equivalent	Mayaguez Medical Center
K931856	5.0 MM IRRIGATION/ASPIRATION PROBE	Aug 10, 1993	Substantially Equivalent	Mayaguez Medical Center
K925024	ORC TAPPERED IRRIGATING PROBE	May 21, 1993	Substantially Equivalent	O.R. Concepts, Inc.
K923908	# 9455 AND #9457 POOLE TIP SUCTION PROBE	May 17, 1993	Substantially Equivalent	O.R. Concepts, Inc.
K920819	ABDOVAC (TM), BELLOVAC (TM) AND EXUDRAIN	Mar 24, 1993	Unknown	Astra Meditec AB
K925989	KENDALL TRU-CLOSE INFECTION CONTROL EVACUATOR	Feb 26, 1993	Substantially Equivalent	Kendall Healthcare Products Co. Div.Of Tyco Health
K925749	KENDALL TRU-CLOSE(TM) SUCTION RESERVOIR, 150 ML	Feb 01, 1993	Substantially Equivalent	Kendall Healthcare Products Co. Div.Of Tyco Health
K922895	J-VAC BULB SUCTION RESERVOIR	Sep 15, 1992	Substantially Equivalent	Johnson & Johnson Medical, Inc.
K915867	SOLCOVAC WOUND DRAINAGE SYSTEM	Aug 14, 1992	Unknown	Solco Basle, Inc.
K915536	DAVOL 100CC SILICONE CLOSED WOUND DRAINAGE EVAC	Mar 26, 1992	Substantially Equivalent	Davol, Inc.
K910167	MICROTEK-HERITAGES SILICONE BULB EVACUATION SYSTEM	Apr 15, 1991	Substantially Equivalent	Microbio-Medics, Inc.
K905733	SEROMA-CATH CLOSE DRAINAGE SYSTEM	Jan 28, 1991	Substantially Equivalent	Dawn Medical
K901764	INAMED CONVERTIBLE DRAIN SYSTEM	May 07, 1990	Substantially Equivalent	Inamed Development Co.
K901742	INAMED SMALL DRAIN SYSTEM	May 07, 1990	Substantially Equivalent	Inamed Development Co.
K896491	INAMED CLOSED-WOUND DRAIN SYSTEM	Jan 08, 1990	Substantially Equivalent	Inamed Development Co.
K896803	CLOSED WOUND RESERVOIR	Dec 27, 1989	Substantially Equivalent	Westmark, Sterile Packing Systems, Inc. (Sps)
K883982	DRENOVAC	Feb 23, 1989	Substantially Equivalent	Iberhospitex, S.A.
K883472	CLOSED WOUND SUCTION DEVICE	Oct 18, 1988	Substantially Equivalent	Westmark, Sterile Packing Systems, Inc. (Sps)
K883433	AMBU TWIN PUMP - (MANUAL SUCTION PUMP)	Sep 02, 1988	Substantially Equivalent	Ambu, Inc.
K881036	HEMO SUC NUMBER HS100-HS205	Jun 20, 1988	Substantially Equivalent	Instrumental Medico Croquevielle S.A.
K881012	WOUND-EVAC RS	Mar 17, 1988	Substantially Equivalent	Heritage Medical Products
K880650	HEYER-SCHULTE(R) 100CC & 400CC EXUDATE DISP. BAGS	Feb 24, 1988	Substantially Equivalent	Baxter Healthcare Corp
K874645	CLOSED WOUND DRAINAGE SYSTEMS	Dec 02, 1987	Substantially Equivalent	Hall Laboratories, Inc.
K873332	MAXIVAC(TM) CLOSED WOUND SUCTION DRAINAGE SYSTEM	Sep 08, 1987	Substantially Equivalent	American V. Mueller
K863482	DRAINOVAC COMPLETE CLOSED WOUND DRAINAGE DEVICE	Oct 14, 1986	Substantially Equivalent	Cardio Metrics, Inc.
K863562	URESIL 150CC BELLOWS RESERVOIR	Sep 29, 1986	Substantially Equivalent	Uresil Corp.
K863505	URESIL CLOSED DRAINAGE RESERVOIR	Sep 18, 1986	Substantially Equivalent	Uresil Corp.
K863201	NEW USE FOR ACUVAC SUCTION RESERVOIR 400CC	Aug 29, 1986	Substantially Equivalent	Allergan, Inc.
K860981	ASPIR-VAC DISPOSABLE SURGICAL DRAIN SYSTEM	May 02, 1986	Substantially Equivalent	Sun Technologies
K854424	BARD PARKER 150CC BELLOWS RESERVOIR	Nov 20, 1985	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K853295	EMODREN EXCHANGEABLE PLASTIC BELLOWS	Aug 20, 1985	Substantially Equivalent	Parexel Intl. Corp.
K850634	SURGIDYNE SURGIFLO C.W.S. DRAIN PRODUCTS	Jun 28, 1985	Substantially Equivalent	Surgidyne, Inc.
K851084	ECONOMY 400 CWS WITH PVC DRAINS	Jun 04, 1985	Substantially Equivalent	C.R. Bard, Inc.
K850011	PROVAC WOUND HEALING/SUCTION SET	May 21, 1985	Substantially Equivalent	Medical Matrix, Inc.
K850037	CLOSED WOUND DRAIN	Mar 19, 1985	Substantially Equivalent	Consolidated Medical Equipment, Inc.
K844921	PERIMETER CLOSED WOUND RESEVOIR	Mar 18, 1985	Substantially Equivalent	Perimeter Medical, Inc.
K842710	CONCEPT C-VAC	Oct 31, 1984	Substantially Equivalent	Concept, Inc.
K840913	PROVAC WOUND DRAINAGE & HEALING SYS	Apr 24, 1984	Substantially Equivalent	Meyer Medical U.S.A., Inc.
K833586	TLS BULB DRAINAGE SYSTEM	Jan 30, 1984	Substantially Equivalent	Porex Medical
K830123	DISP. YANKAVER SURG. SUCTION INSTRUMENT	Jun 08, 1983	Substantially Equivalent	Narco Scientific
K830607	SUCTION RESERVOIR	May 02, 1983	Substantially Equivalent	Sil-Med Corp.
K830510	BBL STREP GROUPING KIT	May 02, 1983	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K823284	STRYKER CONSTAVAC	Jan 14, 1983	Substantially Equivalent	Stryker Corp.
K822902	MINI-VAC DRAIN SYSTEM	Dec 28, 1982	Substantially Equivalent	Angus Medical Co.
K822032	LARGE VOLUME CLOSED WOUND SUCTION DRAIN	Aug 16, 1982	Substantially Equivalent	American Heyer Schulte
K821563	ARGYLE VAC-U-CARE 100CC SUCTION RESERV	Jun 21, 1982	Substantially Equivalent	Sherwood Medical Co.
K820474	P-S SUCTION RESERVIOR	Mar 08, 1982	Substantially Equivalent	Pudenz-Schulte Medical Research Corp.
K813377	PS-ROUND SURG. DRAIN & CONNECTOR	Jan 05, 1982	Substantially Equivalent	Pudenz-Schulte Medical Research Corp.
K813341	WOUND-EVAC	Dec 18, 1981	Substantially Equivalent	Heritage Medical Products
K811557	DEPUY HEMODRAIN	Jul 20, 1981	Substantially Equivalent	Depuy, Inc.
K811203	SAF SINGLE-USE AEROSOL FILTER	May 21, 1981	Substantially Equivalent	Sorensen Research
K810636	VARIODRAIN	May 01, 1981	Substantially Equivalent	Colmed, Ltd.
K810416	SARNS MINI-SUCKER	Mar 05, 1981	Substantially Equivalent	3M Health Care, Sarns
K802973	ISPVAC TM	Dec 19, 1980	Substantially Equivalent	Innovative Surgical Products, Inc.
K802214	COS-UPHOFF INT'L DS-5 DRAINAGE SYSTEM	Oct 23, 1980	Substantially Equivalent	Cox-Uphuff Intl.
K801766	JACKSON-PRATT LARGE VOL. CLOSED WOUND	Aug 20, 1980	Substantially Equivalent	American Heyer Schulte
K801612	FRAZIER-FERGUSON SUCTION TUBES (DISP.)	Aug 04, 1980	Substantially Equivalent	Edward Weck, Inc.
K801443	P-S SUCTION RESERVOIR	Jul 14, 1980	Substantially Equivalent	Pudenz-Schulte Medical Research Corp.
K801442	P-S SURGICAL DRAIN	Jul 14, 1980	Substantially Equivalent	Pudenz-Schulte Medical Research Corp.
K801350	ACUVAC(TM) SUCTION RESERVOIR 400CC AND	Jul 14, 1980	Substantially Equivalent	Innovative Surgical Products, Inc.
K801372	ARGYLE VAC-U-CARE 100CC SUCT. RESERVOIR	Jun 26, 1980	Substantially Equivalent	Sherwood Medical Co.
K801371	ARGYLE VAC-U-CARE FLAT SILICONE WOUND T.	Jun 26, 1980	Substantially Equivalent	Sherwood Medical Co.
K800578	SURGIVAC TM	Apr 16, 1980	Substantially Equivalent	Snyder Laboratories, Inc.
K800577	SNYDER HEMOVAC TM VENTED WOUND KIT	Apr 16, 1980	Substantially Equivalent	Snyder Laboratories, Inc.
K800543	SNYDER HYSTERECTOMY Y TUBE KIT	Apr 16, 1980	Substantially Equivalent	Snyder Laboratories, Inc.
K800581	TLS TM SURGICAL DRAINAGE SYSTEM	Apr 04, 1980	Substantially Equivalent	Glasrock Products, Inc.
K800542	100 ML SNYDER HEMOVAC	Apr 02, 1980	Substantially Equivalent	Snyder Laboratories, Inc.
K800331	SURGITEK FOERSTER FACE LIFT DRAIN	Mar 05, 1980	Substantially Equivalent	Medical Engineering Corp.
K800081	DAVOL/ABAMSON SILICONE SUMP DRAIN	Jan 28, 1980	Substantially Equivalent	Davol, Inc.
K800014	DOW CORNING/W RIGHT WOUND DRAINAGE SYS	Jan 17, 1980	Substantially Equivalent	Dow Corning Corp. Healthcare Industries Materials
K790654	CLOSED WOUND VACUUM DRAINAGE SYSTEM	Apr 26, 1979	Substantially Equivalent	3M Company
K790763	MAXI-VAC TM	Apr 23, 1979	Substantially Equivalent	Med General
K782115	ASTRA-VAC	Feb 01, 1979	Substantially Equivalent	Ab Astra
K782028	ROUND SILICONE DRAIN	Dec 20, 1978	Substantially Equivalent	Davol, Inc.
K782026	FLAT SILICONE DRAIN	Dec 12, 1978	Substantially Equivalent	Davol, Inc.
K781400	HEMOVAC TUBING MATERIAL CHANGE	Sep 20, 1978	Substantially Equivalent	Snyder Laboratories, Inc.
K780848	PORTABLE CLOSED WOUND SUCTION EVACUATOR	Aug 23, 1978	Substantially Equivalent	Biomet, Inc.
K771015	VYGON RED-O-PACK	Jul 11, 1977	Substantially Equivalent	Coastal Bend Medical Products, Inc.
K760778	T-TUBE DRAIN, ROUND	Nov 03, 1976	Substantially Equivalent	Heyer Schulte Corp.
K760700	SILASTIC BRAND G7-2090A	Nov 02, 1976	Substantially Equivalent	Dow Corning Corp. Healthcare Industries Materials
K760747	YASARGIL SUCTION TUBE - MEDIUM	Nov 01, 1976	Substantially Equivalent	Codman & Shurtleff, Inc.
K760746	YASARGIL SUCTION TUBE - LARGE	Nov 01, 1976	Substantially Equivalent	Codman & Shurtleff, Inc.
K760745	YASARGIL SUCTION TUBE - SMALL	Nov 01, 1976	Substantially Equivalent	Codman & Shurtleff, Inc.
K760601	ARGYLE SUCTION CONTROL KIT	Nov 01, 1976	Substantially Equivalent	Sherwood Medical Co.
K760257	SPONGE, RICHARDS WOUND DRAINAGE SYSTEM	Aug 09, 1976	Substantially Equivalent	Richard'S Medical Equip., Inc.