Product Code: GCX FDA class 2 21 CFR 880.6740

Apparatus, Suction, Operating-Room, Wall Vacuum Powered

General Hospital

The Apparatus, Suction, Operating-Room, Wall Vacuum Powered (product code GCX) is a wall-vacuum-powered suction system installed in the operating room to aspirate fluids, blood, and debris from the surgical field during procedures, maintaining a clear operative environment. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. The device is regulated under 21 CFR 880.6740 in the General Hospital specialty (HO). No special flags apply to this device.

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510(k)s

FEI Numbers

193

Registration Numbers

193

Unique Applicants

Years Active

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Basic Information

Product Code: GCX
Device Class: FDA class 2
Regulation Number: 880.6740
Medical Specialty: General Hospital
Review Panel: HO
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 87 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K042454	STRYKER CASSETTE PUMP	Dec 09, 2004	Substantially Equivalent	Stryker Endoscopy
K992126	CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM	Aug 03, 1999	Substantially Equivalent	Circon Corp.
K972074	SUCTION INSTRUMENTATION	Jul 25, 1997	Substantially Equivalent	Walter Lorenz Surgical, Inc.
K971022	CHASE SUCKER	Apr 17, 1997	Substantially Equivalent	Chase Medical, Inc.
K964127	MEDI-VAC FLEXI-CLEAR SUCTION HANDLE	Dec 31, 1996	Substantially Equivalent	Allegiance Healthcare Corp.
K964519	CURITY THORACENTESIS TRAY	Dec 20, 1996	Substantially Equivalent	Kendall Healthcare Products Co. Div.Of Tyco Health
K963648	STRYKER SUCTION REGULATOR	Nov 26, 1996	Substantially Equivalent	Stryker Endoscopy
K962920	RENTON SUCTION DEVICE U.S. PATENT*4,767,404	Oct 21, 1996	Substantially Equivalent	R&S Surgical, LLC
K961880	MEDCARE SUCTION CONNECTING TUBING	Jul 19, 1996	Substantially Equivalent	Medcare Medical Group, Inc.
K960223	CPR YANKAUER	Mar 28, 1996	Substantially Equivalent	Custom Pack Reliability
K954869	MEDCARE YANKAUER SUCTION DEVICE	Jan 19, 1996	Substantially Equivalent	Medcare Custom Packaging, Inc.
K954726	STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION)	Nov 29, 1995	Substantially Equivalent	Stryker Endoscopy
K952219	SUCTION TIP CLEANER CUP	Nov 15, 1995	Substantially Equivalent	Moore/Gobel
K951119	NEZHAT-DORSEY SPECIMEN CONTAINER SYSTEM	Jun 13, 1995	Substantially Equivalent	American Hydro-Surgical Instruments, Inc.
K950464	SSCOR/BOARD ..3 MODEL 23000 PRE-ASSEMBLED SUCTION SYSTEM FOR PATIENT TRANSPORT VEHICLES	Apr 25, 1995	Substantially Equivalent	Sscor
K931548	INAMED DEVELOPMENT ASPIRATION TIP	Jan 10, 1994	Substantially Equivalent	Inamed Development Co.
K924570	OEM MULTI-VAC POWERED SUCTION PUMP	Aug 05, 1993	Substantially Equivalent	Oem Medical Div.
K920912	THE MEDIC TM	Jul 30, 1993	Substantially Equivalent	Medical and Environment Designs, Inc.
K924337	PLEUR-EVAC(R) ADULT/PEDI DUAL COLL CHEST DRAIN SYS	Jul 28, 1993	Substantially Equivalent	Deknatel, Inc.
K924577	MEDIVAC	Mar 23, 1993	Substantially Equivalent	Medisonic U.S.A., Inc.
K911238	TAHOE SUCTION IRRIGATOR	Nov 27, 1992	Substantially Equivalent	Tahoe Pro Instruments
K920248	MODEL SLASE 210 HOLMIUM LASER SYSTEM	Jul 21, 1992	Unknown	Sunrise Technologies, Inc.
K914601	SUCTION CONNECTING TUBING	Feb 07, 1992	Substantially Equivalent	Bemis Mfg. Co.
K912753	XOMED-TREACE POSITROL FOOTPEDAL SUCTION CONTROL	Sep 23, 1991	Substantially Equivalent	Xomed-Treace, Inc.
K910377	COOPERSURGICAL MODEL 6080 SMOKE EVACUATOR SYSTEM	Apr 19, 1991	Substantially Equivalent	CooperSurgical, Inc.
K910218	LAPAROMED CHOLANGIOGRAM VACUUM DEVICE	Apr 08, 1991	Substantially Equivalent	Laparomed Corp.
K905448	THORA-KLEX CHEST DRAINAGE UNIT	Mar 27, 1991	Substantially Equivalent	Davol, Inc.
K895859	CONTAIN(TM)	Feb 07, 1991	Substantially Equivalent	Arbor Technologies, Inc.
K896134	ACUFLO, VACUUM-POWERED BODY FLUID SUCTION APPARA.	Aug 30, 1990	Substantially Equivalent	Goosen Enterprises, Inc.
K901937	CODMAN SUCTION PATTIE	Jul 16, 1990	Substantially Equivalent	Codman & Shurtleff, Inc.
K902089	EQUI-GUARD (ASPIRATOR FILTER)	Jul 06, 1990	Substantially Equivalent	Equi-Tron Mfg., Inc.
K896804	MANIFOLD	Feb 08, 1990	Substantially Equivalent	Westmark, Sterile Packing Systems, Inc. (Sps)
K896563	TUBING CONNECTORS	Feb 06, 1990	Substantially Equivalent	Westmark, Sterile Packing Systems, Inc. (Sps)
K896562	STOPCOCK	Feb 06, 1990	Substantially Equivalent	Westmark, Sterile Packing Systems, Inc. (Sps)
K896558	YANKAUER SUCTION TUBE-RIGID TYPE	Feb 06, 1990	Substantially Equivalent	Westmark, Sterile Packing Systems, Inc. (Sps)
K896557	YANKAUER SUCTION TUBE-FLEXIBLE TYPE	Feb 06, 1990	Substantially Equivalent	Westmark, Sterile Packing Systems, Inc. (Sps)
K896556	UNIVERSAL POOLE SUCTION TUBE	Feb 06, 1990	Substantially Equivalent	Westmark, Sterile Packing Systems, Inc. (Sps)
K894695	VACUSAFE DISP. VACUUM - EXTRACTION SYSTEM	Jan 22, 1990	Substantially Equivalent	Medistad Corp.
K895039	STERILE SALINE - FOR SUCTION CATHETER LUBRICATION	Oct 03, 1989	Substantially Equivalent	Aplicare, Inc.
K893649	MECONIUM ASPIRATOR	Aug 21, 1989	Substantially Equivalent	Gish Biomedical, Inc.
K893741	RECEPTAL (R) SAF-GARD(TM) SUCTION LINER	Aug 17, 1989	Substantially Equivalent	Abbott Laboratories
K892549	SUCTION TUBES: HOUSE, BARON	May 18, 1989	Substantially Equivalent	Zinnanti Surgical Instruments, Inc.
K890129	PLEUR-EVAC(R) A-8020--INFANT CHEST DRAINAGE SYSTEM	Apr 10, 1989	Substantially Equivalent	Deknatel, Inc.
K890431	PLEUR-EVAC(R) A-8000--ADULT/PEDIATRIC CHEST DRAIN	Apr 04, 1989	Substantially Equivalent	Deknatel, Inc.
K885208	RECEPTAL SAF-GARD(TM) SYSTEM	Mar 17, 1989	Unknown	Abbott Laboratories
K885334	VAC-RITE	Mar 08, 1989	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K884103	REMOTE VACUUM BOOSTER SYSTEM, 7600 SERIES	Mar 03, 1989	Substantially Equivalent	Boehringer Laboratories
K881252	PLEUR-EVAC(R) A6000 ADULT/PEDIATRIC CHEST DRAINAGE	Jun 17, 1988	Substantially Equivalent	Deknatel, Inc.
K874505	CONTAIN(TM)	May 20, 1988	Substantially Equivalent	Arbor Technologies, Inc.
K870874	CSPI SPECIMEN TRAP (NON-STERILE)	Apr 19, 1988	Substantially Equivalent	Custom Surgical Products, Inc.
K880704	CERULLO SUCTION REGULATOR	Mar 29, 1988	Substantially Equivalent	Aesculap Instruments Corp.
K873489	EMERSON DISPOS THORACIC DRAINAGE SET - 551-8000	Dec 29, 1987	Substantially Equivalent	J. H. Emerson Co.
K861261	OHMEDA POSI-PULSE SUCTION UNIT	May 30, 1986	Substantially Equivalent	Ohmeda Medical
K853095	BOEHRINGER LABORATORIES SUCTION INTERMITTOR	Aug 23, 1985	Substantially Equivalent	Boehringer Laboratories
K851384	MEDICAL/SURGICAL SUCTION SYSTEM	May 08, 1985	Substantially Equivalent	Puritan Bennett Corp.
K844882	RICO RS-6X EMERGENCY MEDICAL ASPIRATOR	Mar 01, 1985	Substantially Equivalent	Rico Suction Laboratories, Inc.
K844881	RICO RS4-XP EMERGENCY MEDICAL ASPIRATOR	Mar 01, 1985	Substantially Equivalent	Rico Suction Laboratories, Inc.
K833674	ACCURATE MEASUREMENT DEVICE KG-AMD	Jan 25, 1984	Substantially Equivalent	Sorensen Research
K833673	ACCURATE MEASUREMENT DEVICE EZ-AMD	Dec 29, 1983	Substantially Equivalent	Sorensen Research
K831116	INVAC W/VARIOUS MODELS	Aug 12, 1983	Substantially Equivalent	Pmt
K831939	TALL FLOOR STAND TFS-01	Jul 19, 1983	Substantially Equivalent	Sorensen Research
K823037	PLEUR-EVAC A-4005 SYSTEM	Oct 28, 1982	Substantially Equivalent	Howmedica Corp.
K822311	DISPOSABLE COLLECTION BOTTLE W/TUBING	Aug 20, 1982	Substantially Equivalent	Ohio Medical Products
K822005	SPECIMEN COLLECTORS	Jul 28, 1982	Substantially Equivalent	Kelleher Corp.
K821841	MEDIGAS SUCTION/DRAINAGE EQUIPMENT	Jul 02, 1982	Substantially Equivalent	Linde Div. Union Carbide Corp.
K821160	PNEUMO DRAIN T.M. RECORDER #PD-800	May 27, 1982	Substantially Equivalent	Sugen Industries, Inc.
K821023	THORACIC DRAINAGE SYSTEM	May 21, 1982	Substantially Equivalent	Howmedica Corp.
K820765	PLEURAL DRAINAGE RESERVOIR	Apr 15, 1982	Substantially Equivalent	Innovative Surgical Products, Inc.
K820424	IMPACT, MODEL 310	Mar 12, 1982	Substantially Equivalent	Impact Instrumentation, Inc.
K820337	IMPACT, MODEL 303	Mar 02, 1982	Substantially Equivalent	Impact Instrumentation, Inc.
K813394	DS-7 CLOSED WOUND SUCTION DRAIN SYSTEM	Jan 22, 1982	Substantially Equivalent	Cox-Uphuff Intl.
K813319	ASPIRATOR VENTURI SYSTEM MODEL 55-JV	Dec 14, 1981	Substantially Equivalent	J. H. Emerson Co.
K813029	VALVED SURGICAL ASPIRATORS	Dec 14, 1981	Substantially Equivalent	Imedix
K813066	ARGYLE YANKAUER SUCTION TUBE	Nov 16, 1981	Substantially Equivalent	Sherwood Medical Co.
K812845	SURGICAL SUCTION INSTRUMENTS-DISPOS.	Nov 16, 1981	Substantially Equivalent	Abco Dealers, Inc.
K802440	ARGYLE COMPACT CHEST DRAINAGE SYS.	Oct 23, 1980	Substantially Equivalent	Sherwood Medical Co.
K801979	ARGYLE COMPACT CHEST DRAINAGE SYSTEM	Sep 16, 1980	Substantially Equivalent	Sherwood Medical Co.
K801942	OHIO THORACIC COLLECTION UNIT	Sep 16, 1980	Substantially Equivalent	Ohio Medical Products
K790055	TUBING, DYNACOR UNIVERSAL	Feb 22, 1979	Substantially Equivalent	Medline Industries, Inc.
K781988	SUCTION APPARATUS, POWERED BY COMP. AIR	Dec 12, 1978	Substantially Equivalent	Farley, W.T.
K771737	SUCTION CANISTER	Dec 20, 1977	Substantially Equivalent	Bemis Health Care
K760814	HEPARINIZED PENROSE TUBING	Nov 03, 1976	Substantially Equivalent	Sherwood Medical Industries
K760813	HEPARINIZED SARATOGA SUMP DRAIN	Nov 03, 1976	Substantially Equivalent	Sherwood Medical Industries
K760812	HEPARINIZED WOUND SUCTION TUBING	Nov 03, 1976	Substantially Equivalent	Sherwood Medical Industries
K760333	JAR, COLLECTOR FOR SUCTION SYSTEMS	Oct 27, 1976	Substantially Equivalent	Harris-Lake, Inc.
K760217	SUCTION INSTRUMENT, MACBICK DIS. FRAZ.	Aug 23, 1976	Substantially Equivalent	C.R. Bard, Inc.
K760216	SUCTION INSTRUMENT, MACBICK POOLE TIP	Aug 23, 1976	Substantially Equivalent	C.R. Bard, Inc.