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Innolitics
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Review Panel
Cardiovascular
Review Panel
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Review Panel
Miscellaneous
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart C—General Hospital and Personal Use Monitoring Devices
CFR Sub-Part
Subpart D—Pathology Instrumentation and Accessories
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
BRZ
Set, Blood Transfusion
2
Product Code
BWJ
Locator, Acupuncture Point
2
Product Code
CAK
Microfilter, Blood Transfusion
2
Product Code
DWL
Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
2
Product Code
FMF
Syringe, Piston
2
Product Code
FMG
Stopcock, I.V. Set
2
Product Code
K
22
3499
Three Way Stop Cock
2
Cleared 510(K)
K
22
3175
lntravascular Administration Sets with Stopcock and Manifold
2
Cleared 510(K)
K
21
1204
SafePort(TM) Manifold (or Stopcock)
2
Cleared 510(K)
K
21
0516
Clicky Cross
2
Cleared 510(K)
K
19
0539
TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile
2
Cleared 510(K)
K
19
0489
Elcam Stopcocks and Manifolds
2
Cleared 510(K)
K
17
2266
Dynarex Three-Way Stopcock
2
Cleared 510(K)
K
14
1254
ELCAM STOPCOCKS AND MANIFOLDS
2
Cleared 510(K)
K
12
3084
DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD
2
Cleared 510(K)
K
13
0245
LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO
2
Cleared 510(K)
K
08
2110
DUAL SYRINGE HOLDER
2
Cleared 510(K)
K
08
2836
ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES
2
Cleared 510(K)
K
08
2106
ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS)
2
Cleared 510(K)
K
08
0077
CLAVE STOPCOCK
2
Cleared 510(K)
K
07
1400
SMARTSITE STOPCOCK
2
Cleared 510(K)
K
07
0143
JMS PLANECTA STOPCOCK
2
Cleared 510(K)
K
05
3405
BACSTOP
2
Cleared 510(K)
K
06
1143
ROBERTSITE STOPCOCK
2
Cleared 510(K)
K
06
0231
CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCK
2
Cleared 510(K)
K
05
2330
TRU-SWAB STOCOCK
2
Cleared 510(K)
K
04
1779
NIPRO DISPOSABLE STOPCOCKS, MODELS 3W-RC. NCN-3, 3W-R, 3W-L
2
Cleared 510(K)
K
03
2393
INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK)
2
Cleared 510(K)
K
02
2895
ELCAM STOPCOCKS AND MANIFOLDS
2
Cleared 510(K)
K
01
2157
CHURCHILL MEDICAL SYSTEMS STOPCOCK
2
Cleared 510(K)
K
01
0217
4 PORT, 4 WAY STOPCOCK
2
Cleared 510(K)
K
98
2368
MANIFOLD WITH EXTENSION SET
2
Cleared 510(K)
K
97
4083
CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKS
2
Cleared 510(K)
K
96
4435
PRIMARY IV SET
2
Cleared 510(K)
K
96
1982
TRI-FLOW THREE WAY STOPCOCK
2
Cleared 510(K)
K
96
2581
STOPCOCK MANIFOLD GANGS
2
Cleared 510(K)
K
95
4970
STOPCOCK & LUER LOCK PLUG
2
Cleared 510(K)
K
95
5782
MED-NET STOPCOCKS
2
Cleared 510(K)
K
95
4984
MINIBORE STOPCOCK SET
2
Cleared 510(K)
K
95
3573
ICU STOPCOK WITH EXTENSION TUBING
2
Cleared 510(K)
K
94
0070
STOPCOCK INTRAVENOUS THERAPY
2
Cleared 510(K)
K
93
2512
MULTI-PORT MANIFOLD
2
Cleared 510(K)
K
91
3560
STOPCOCK
2
Cleared 510(K)
K
91
1415
TRUMPET VALVE
2
Cleared 510(K)
K
90
2724
ADVANCE DISPOSABLE STOPCOCK
2
Cleared 510(K)
K
89
1234
TERUFUSION THREE WAY STOPCOCK
2
Cleared 510(K)
K
88
4463
CONNECTA MONOFLO & MULTIFLO INFUSION CONNECTORS
2
Cleared 510(K)
K
88
4435
RESUBMITTED 1,3 & 4 WAY STOPCOCKS, VARIOUS PARTS
2
Cleared 510(K)
K
88
1805
TU STOPCOCK
2
Cleared 510(K)
K
87
2067
STERICAP ASSEMBLY AND REPLACEMENT TRAY
2
Cleared 510(K)
K
87
2066
STERICAP STOPCOCK
2
Cleared 510(K)
K
86
4900
VIGGO EXACTA PRESSURE MONITORING KIT
2
Cleared 510(K)
K
87
0261
VIGGO EXACTA PRESSURE MONITORING SYSTEM
2
Cleared 510(K)
K
87
0324
#014460-120 3-WAY & #014461-120 4-WAY STOPCOCK
2
Cleared 510(K)
K
86
4440
CHURCHILL 3-WAY STOPCOCK
2
Cleared 510(K)
K
86
2492
EXEL THREE-WAY STOPCOCK
2
Cleared 510(K)
K
86
2691
STOPCOCK
2
Cleared 510(K)
K
86
0889
SAMPLE MANIFOLD HOLDER
2
Cleared 510(K)
K
85
4348
CHURCHILL 3-WAY STOPCOCK SET
2
Cleared 510(K)
K
85
3275
CLICK LOCK MULTI-VAS INFECTION CONTROL MANIFOLD
2
Cleared 510(K)
K
85
1986
STOPCOCKS
2
Cleared 510(K)
K
85
0280
VIGGO CONNECTA 3-WAY INFUSION STOPCOCK
2
Cleared 510(K)
K
84
2173
DISPOSABLE STOPCOCKS
2
Cleared 510(K)
K
84
0394
STOPCOCKS & EXTENSION TUBES
2
Cleared 510(K)
K
83
0198
PEDIATRIC EXTEN. SET FOR SECOND-DRUG
2
Cleared 510(K)
K
82
3469
TERUFUSION THREE-WAY STOPCOCK
2
Cleared 510(K)
K
82
3373
BENZING RETROGRADE ADMIN. SET
2
Cleared 510(K)
K
82
3120
EXACTA & CONNECTA STOPCOCKS W/EXTENSION
2
Cleared 510(K)
K
82
0165
FLOW MED 311
2
Cleared 510(K)
K
81
2927
ARTERIOGRAM TRAY
2
Cleared 510(K)
K
81
0375
CENTURION STOPCOCK 3 WAY
2
Cleared 510(K)
K
80
2258
STOPCOCK 2-WAY, 3-WAY & 4-WAY
2
Cleared 510(K)
K
80
0862
1,3 & 4 WAY STERILE DIS. PLASTIC PKG.
2
Cleared 510(K)
K
80
0863
TANDEM ASSEMBED 3&4 WAY STERILE STOPCKS
2
Cleared 510(K)
K
80
0864
STERILE DISPOS. PLASTIC STOPCOCKS W/TUBE
2
Cleared 510(K)
K
80
0284
THREE-WAY STOPCOCK EXTENSION SET 20-SL
2
Cleared 510(K)
K
79
2128
STERILE EXTENSION TUBES INDIV. PKG.
2
Cleared 510(K)
K
79
2127
PLAS. STCK. W/EXTENSION TUBE/STERILE
2
Cleared 510(K)
K
79
2126
3&4 WAY PLASTIC STERILE STPCKS. PKG.
2
Cleared 510(K)
K
79
2125
3&4 WAY PLASTIC STOPCOCKS, NONSTERILE
2
Cleared 510(K)
K
79
2124
TANDEM ASSEMBLED 3&4 WAY STOPCOCKS
2
Cleared 510(K)
K
78
2168
3-WAY STOPCOCK
2
Cleared 510(K)
K
78
2167
DELTA FLOW
2
Cleared 510(K)
K
79
0010
MANIFOLD, DISPOSABLE 3 VALVE
2
Cleared 510(K)
K
78
0662
SUPPLEMENTAL TYGON PAC-MONITORING LINES
2
Cleared 510(K)
K
78
0596
STOPCOCK
2
Cleared 510(K)
K
77
1911
PLASTIC STOPCOCK W/ EXTENSION TUBE
2
Cleared 510(K)
K
77
0916
TYGON PAC-MONITORING LINES & FLUID ADMIN
2
Cleared 510(K)
K
77
0708
TYGON PAC-STOPCOCKS
2
Cleared 510(K)
K
77
0707
TYGON PAC-MONITORING LINES & FLUID ADMIN
2
Cleared 510(K)
K
76
0678
4-WAY STOPCOCK W/100 CM TUBING, LUER-LK
2
Cleared 510(K)
K
76
0679
4-WAY STOPCOCK W/7CM TUBING,
2
Cleared 510(K)
K
76
0667
4-WAY STOPCOCK W/10 CM EXTEN. TUBING
2
Cleared 510(K)
K
76
0666
4-WAY STOPCOCK W/LUER-LOCK FITTING
2
Cleared 510(K)
FMI
Needle, Hypodermic, Single Lumen
2
Product Code
FMS
Bed, Pediatric Open Hospital
2
Product Code
FMT
Warmer, Infant Radiant
2
Product Code
FMZ
Incubator, Neonatal
2
Product Code
FNG
Lift, Patient, Ac-Powered
2
Product Code
FNJ
Bed, Manual
1
Product Code
FNK
Bed, Hydraulic, Adjustable Hospital
1
Product Code
FNL
Bed, Ac-Powered Adjustable Hospital
2
Product Code
FNM
Mattress, Air Flotation, Alternating Pressure
2
Product Code
FNN
Nipple, Lambs Feeding
1
Product Code
FOD
Device, Occlusion, Umbilical
1
Product Code
FOH
Mattress, Water, Temperature Regulated
1
Product Code
FOK
Pad, Neonatal Eye
1
Product Code
FOS
Catheter, Umbilical Artery
2
Product Code
FOZ
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
2
Product Code
FPA
Set, Administration, Intravascular
2
Product Code
FPB
Filter, Infusion Line
2
Product Code
FPK
Tubing, Fluid Delivery
2
Product Code
FPL
Incubator, Neonatal Transport
2
Product Code
FQH
Lavage, Jet
2
Product Code
FQJ
Support, Scrotal, Therapeutic
1
Product Code
FQK
Binder, Perineal
1
Product Code
FQL
Stocking, Medical Support (For General Medical Purposes)
1
Product Code
FQM
Bandage, Elastic
1
Product Code
FRF
Cleaner, Air, Medical Recirculating
2
Product Code
FRL
Fiber, Medical, Absorbent
1
Product Code
FRN
Pump, Infusion
2
Product Code
FRP
Holder, Infant Position
1
Product Code
FRR
Chamber, Reverse Isolation, Patient Care
2
Product Code
FSA
Lift, Patient, Non-Ac-Powered
1
Product Code
FSD
Binder, Abdominal
1
Product Code
HEF
Binder, Breast
1
Product Code
HFS
Shield, Nipple
1
Product Code
IKY
Mattress, Flotation Therapy, Non-Powered
1
Product Code
KMK
Device, Intravascular Catheter Securement
1
Product Code
KMO
Binder, Elastic
1
Product Code
KPE
Container, I.V.
2
Product Code
KYP
Snake Bite Suction Kit
1
Product Code
KYQ
Kit, Chemical Snake-Bite
3
Product Code
KZD
Infusor, Pressure, For I.V. Bags
1
Product Code
KZE
Injector, Fluid, Non-Electrically Powered
2
Product Code
LBI
Unit, Neonatal Phototherapy
2
Product Code
LDR
Controller, Infusion, Intravascular, Electronic
2
Product Code
LGM
Chamber, Patient Isolation
2
Product Code
LGN
Chamber, Patient Transport Isolation
2
Product Code
LGZ
Warmer, Thermal, Infusion Fluid
2
Product Code
LHF
Warmer, Microwave, Infusion Fluid
2
Product Code
LHI
Set, I.V. Fluid Transfer
2
Product Code
LJL
Detectors And Removers, Lice, (Including Combs)
1
Product Code
LJS
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
2
Product Code
LJT
Port & Catheter, Implanted, Subcutaneous, Intravascular
2
Product Code
LLI
Bed, Therapeutic, Ac-Powered, Adjustable Home-Use
2
Product Code
LLK
Legging, Compression, Non-Inflatable
2
Product Code
LZH
Pump, Infusion, Enteral
2
Product Code
MDR
Binder, Medical, Therapeutic
1
Product Code
MEA
Pump, Infusion, Pca
2
Product Code
MEB
Pump, Infusion, Elastomeric
2
Product Code
MEG
Syringe, Antistick
2
Product Code
MHC
Needle, Interosseous
2
Product Code
MHD
Pump, Infusion, Gallstone Dissolution
2
Product Code
MJF
Check Valve, Retrograde Flow (In-Line)
2
Product Code
MMK
Container, Sharps
2
Product Code
MQX
Needle, Acupuncture, Single Use
2
Product Code
MRZ
Accessories, Pump, Infusion
2
Product Code
MZR
Topical Approximation System
1
Product Code
NEP
System/Device, Pharmacy Compounding
2
Product Code
NGT
Saline, Vascular Access Flush
2
Product Code
NKK
Needle, Hypodermic, Single Lumen, Reprocessed
2
Product Code
NKN
Syringe, Piston, Reprocessed
2
Product Code
NRW
Stimulator, Intramuscular, Automatic
2
Product Code
NSC
Injector, Pen
2
Product Code
NTC
Nursing Pad, Hydrogel
1
Product Code
NTX
Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)
1
Product Code
NXH
Nursing Pad, Cohesive Gel
1
Product Code
NZG
Bassinet, Hospital
2
Product Code
NZW
Heparin, Vascular Access Flush
2
Product Code
NZX
Water, Vascular Access Flush
2
Product Code
OBK
Port, Protector/Cushion
2
Product Code
ODI
Administration Set Docking Station
2
Product Code
ODY
Tunneled Catheter Remover
2
Product Code
OJA
Intravenous Extension Tubing Set
2
Product Code
OKC
Implanted Subcutaneous Securement Catheter
2
Product Code
OKE
Port Introducer Kit
2
Product Code
OKL
Intravascular Administration Set, Automated Air Removal System
2
Product Code
OMF
Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position
2
Product Code
ONB
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
2
Product Code
ONM
Radiant Infant Warmer Cabinet
2
Product Code
PUK
Administration Set Securement Device
1
Product Code
OPP
Pump, Infusion, Insulin Bolus
2
Product Code
OSI
Bariatric Bed
2
Product Code
OUW
Infant Positioner, Rx, Use In Highly Monitored Setting
1
Product Code
OWL
Peripheral Catheter Insertion Kit
2
Product Code
PDH
Blanket, Neonatal Phototherapy
2
Product Code
PEF
Heparin Flush In 0.45% Sodium Chloride
2
Product Code
PEZ
Central Venous Catheter Dressing Change Kit
2
Product Code
PHC
Infusion Safety Management Software
2
Product Code
PKP
Immunoglobulin G (Igg) Infusion System
2
Product Code
PMS
Peripheral Intravenous (Piv) Infiltration Monitor
2
Product Code
PND
Midline Catheter
2
Product Code
POQ
Blood Transfusion Kit
2
Product Code
POR
Parenteral Administration Kit
2
Product Code
PQH
Iodinated Contrast Media Transfer Tubing Set
2
Product Code
PQX
Epinephrine Syringe
2
Product Code
PRN
Pediatric Position Holder
1
Product Code
PTD
Subcutaneous Implanted Apheresis Port
2
Product Code
PTI
Non-Coring (Huber) Needle
2
Product Code
PUN
Lice Removal Kit Containing A Solution
1
Product Code
PUR
Vacuum Syringe
2
Product Code
PVZ
Non-Stainless Steel Needle
2
Product Code
PWH
Administrations Sets With Neuraxial Connectors
2
Product Code
PWN
Baby Care Kit
2
Product Code
PWO
Blood Administration Kit
2
Product Code
PWQ
Buret Administration Intravenous Kit
2
Product Code
PWR
Catheter Repair Kit
2
Product Code
PWX
Insect Sting Emergency Kit
1
Product Code
PWY
Lumbar Puncture Tray (Adult & Pediatric)
2
Product Code
PXB
Percutaneous Introducer Kit
2
Product Code
PXI
Thoracentesis Tray
2
Product Code
PXJ
Umbilical Catheter Insertion Tray
2
Product Code
PXK
Vascular Access Port Kit
2
Product Code
PXL
Venipuncture Kit
2
Product Code
PYR
Neuraxial Administration Set - Intrathecal Delivery
2
Product Code
PZW
Catheter Access Cover, Tamper-Resistant
2
Product Code
QBL
Piston Syringe Lever
2
Product Code
QDM
Midazolam Syringe
2
Product Code
QEH
Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact
2
Product Code
QJY
Infusion Pump, Drug Specific, Pharmacy-Filled
2
Product Code
QLF
On-Body Injector
2
Product Code
QLY
Ophthalmic Syringe
2
Product Code
QMT
Prep Kit – Vaccine Injection
2
Product Code
QNQ
Low Dead Space Piston Syringe
2
Product Code
QNS
Low Dead Space Needle, Single Lumen, Hypodermic
2
Product Code
QOG
Injection Data Capture Device
2
Product Code
QOI
Intravenous Catheter Force-Activated Separation Device.
2
Product Code
QTI
Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device
2
Product Code
QYM
Ophthalmic Needle
2
Product Code
SCL
Allergen And Vaccine Delivery Needles
2
Product Code
SEF
Central Venous Catheter With Manual Insertion System
2
Product Code
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—General Hospital and Personal Use Miscellaneous Devices
CFR Sub-Part
Subpart G—Miscellaneous Devices
CFR Sub-Part
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 16 May 2025 at 11:05 pm
HO
/
subpart-f—general-hospital-and-personal-use-therapeutic-devices
/
FMG
/
K872066
View Source
STERICAP STOPCOCK
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K872066
510(k) Type
Traditional
Applicant
STERICAP SYSTEMS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/4/1987
Days to Decision
67 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—General Hospital and Personal Use Monitoring Devices
Subpart D—Pathology Instrumentation and Accessories
Subpart D—Prosthetic Devices
Subpart E—Surgical Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
BRZ
Set, Blood Transfusion
BWJ
Locator, Acupuncture Point
CAK
Microfilter, Blood Transfusion
DWL
Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
FMF
Syringe, Piston
FMG
Stopcock, I.V. Set
K
22
3499
Three Way Stop Cock
K
22
3175
lntravascular Administration Sets with Stopcock and Manifold
K
21
1204
SafePort(TM) Manifold (or Stopcock)
K
21
0516
Clicky Cross
K
19
0539
TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile
K
19
0489
Elcam Stopcocks and Manifolds
K
17
2266
Dynarex Three-Way Stopcock
K
14
1254
ELCAM STOPCOCKS AND MANIFOLDS
K
12
3084
DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD
K
13
0245
LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO
K
08
2110
DUAL SYRINGE HOLDER
K
08
2836
ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES
K
08
2106
ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS)
K
08
0077
CLAVE STOPCOCK
K
07
1400
SMARTSITE STOPCOCK
K
07
0143
JMS PLANECTA STOPCOCK
K
05
3405
BACSTOP
K
06
1143
ROBERTSITE STOPCOCK
K
06
0231
CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCK
K
05
2330
TRU-SWAB STOCOCK
K
04
1779
NIPRO DISPOSABLE STOPCOCKS, MODELS 3W-RC. NCN-3, 3W-R, 3W-L
K
03
2393
INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK)
K
02
2895
ELCAM STOPCOCKS AND MANIFOLDS
K
01
2157
CHURCHILL MEDICAL SYSTEMS STOPCOCK
K
01
0217
4 PORT, 4 WAY STOPCOCK
K
98
2368
MANIFOLD WITH EXTENSION SET
K
97
4083
CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKS
K
96
4435
PRIMARY IV SET
K
96
1982
TRI-FLOW THREE WAY STOPCOCK
K
96
2581
STOPCOCK MANIFOLD GANGS
K
95
4970
STOPCOCK & LUER LOCK PLUG
K
95
5782
MED-NET STOPCOCKS
K
95
4984
MINIBORE STOPCOCK SET
K
95
3573
ICU STOPCOK WITH EXTENSION TUBING
K
94
0070
STOPCOCK INTRAVENOUS THERAPY
K
93
2512
MULTI-PORT MANIFOLD
K
91
3560
STOPCOCK
K
91
1415
TRUMPET VALVE
K
90
2724
ADVANCE DISPOSABLE STOPCOCK
K
89
1234
TERUFUSION THREE WAY STOPCOCK
K
88
4463
CONNECTA MONOFLO & MULTIFLO INFUSION CONNECTORS
K
88
4435
RESUBMITTED 1,3 & 4 WAY STOPCOCKS, VARIOUS PARTS
K
88
1805
TU STOPCOCK
K
87
2067
STERICAP ASSEMBLY AND REPLACEMENT TRAY
K
87
2066
STERICAP STOPCOCK
K
86
4900
VIGGO EXACTA PRESSURE MONITORING KIT
K
87
0261
VIGGO EXACTA PRESSURE MONITORING SYSTEM
K
87
0324
#014460-120 3-WAY & #014461-120 4-WAY STOPCOCK
K
86
4440
CHURCHILL 3-WAY STOPCOCK
K
86
2492
EXEL THREE-WAY STOPCOCK
K
86
2691
STOPCOCK
K
86
0889
SAMPLE MANIFOLD HOLDER
K
85
4348
CHURCHILL 3-WAY STOPCOCK SET
K
85
3275
CLICK LOCK MULTI-VAS INFECTION CONTROL MANIFOLD
K
85
1986
STOPCOCKS
K
85
0280
VIGGO CONNECTA 3-WAY INFUSION STOPCOCK
K
84
2173
DISPOSABLE STOPCOCKS
K
84
0394
STOPCOCKS & EXTENSION TUBES
K
83
0198
PEDIATRIC EXTEN. SET FOR SECOND-DRUG
K
82
3469
TERUFUSION THREE-WAY STOPCOCK
K
82
3373
BENZING RETROGRADE ADMIN. SET
K
82
3120
EXACTA & CONNECTA STOPCOCKS W/EXTENSION
K
82
0165
FLOW MED 311
K
81
2927
ARTERIOGRAM TRAY
K
81
0375
CENTURION STOPCOCK 3 WAY
K
80
2258
STOPCOCK 2-WAY, 3-WAY & 4-WAY
K
80
0862
1,3 & 4 WAY STERILE DIS. PLASTIC PKG.
K
80
0863
TANDEM ASSEMBED 3&4 WAY STERILE STOPCKS
K
80
0864
STERILE DISPOS. PLASTIC STOPCOCKS W/TUBE
K
80
0284
THREE-WAY STOPCOCK EXTENSION SET 20-SL
K
79
2128
STERILE EXTENSION TUBES INDIV. PKG.
K
79
2127
PLAS. STCK. W/EXTENSION TUBE/STERILE
K
79
2126
3&4 WAY PLASTIC STERILE STPCKS. PKG.
K
79
2125
3&4 WAY PLASTIC STOPCOCKS, NONSTERILE
K
79
2124
TANDEM ASSEMBLED 3&4 WAY STOPCOCKS
K
78
2168
3-WAY STOPCOCK
K
78
2167
DELTA FLOW
K
79
0010
MANIFOLD, DISPOSABLE 3 VALVE
K
78
0662
SUPPLEMENTAL TYGON PAC-MONITORING LINES
K
78
0596
STOPCOCK
K
77
1911
PLASTIC STOPCOCK W/ EXTENSION TUBE
K
77
0916
TYGON PAC-MONITORING LINES & FLUID ADMIN
K
77
0708
TYGON PAC-STOPCOCKS
K
77
0707
TYGON PAC-MONITORING LINES & FLUID ADMIN
K
76
0678
4-WAY STOPCOCK W/100 CM TUBING, LUER-LK
K
76
0679
4-WAY STOPCOCK W/7CM TUBING,
K
76
0667
4-WAY STOPCOCK W/10 CM EXTEN. TUBING
K
76
0666
4-WAY STOPCOCK W/LUER-LOCK FITTING
FMI
Needle, Hypodermic, Single Lumen
FMS
Bed, Pediatric Open Hospital
FMT
Warmer, Infant Radiant
FMZ
Incubator, Neonatal
FNG
Lift, Patient, Ac-Powered
FNJ
Bed, Manual
FNK
Bed, Hydraulic, Adjustable Hospital
FNL
Bed, Ac-Powered Adjustable Hospital
FNM
Mattress, Air Flotation, Alternating Pressure
FNN
Nipple, Lambs Feeding
FOD
Device, Occlusion, Umbilical
FOH
Mattress, Water, Temperature Regulated
FOK
Pad, Neonatal Eye
FOS
Catheter, Umbilical Artery
FOZ
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
FPA
Set, Administration, Intravascular
FPB
Filter, Infusion Line
FPK
Tubing, Fluid Delivery
FPL
Incubator, Neonatal Transport
FQH
Lavage, Jet
FQJ
Support, Scrotal, Therapeutic
FQK
Binder, Perineal
FQL
Stocking, Medical Support (For General Medical Purposes)
FQM
Bandage, Elastic
FRF
Cleaner, Air, Medical Recirculating
FRL
Fiber, Medical, Absorbent
FRN
Pump, Infusion
FRP
Holder, Infant Position
FRR
Chamber, Reverse Isolation, Patient Care
FSA
Lift, Patient, Non-Ac-Powered
FSD
Binder, Abdominal
HEF
Binder, Breast
HFS
Shield, Nipple
IKY
Mattress, Flotation Therapy, Non-Powered
KMK
Device, Intravascular Catheter Securement
KMO
Binder, Elastic
KPE
Container, I.V.
KYP
Snake Bite Suction Kit
KYQ
Kit, Chemical Snake-Bite
KZD
Infusor, Pressure, For I.V. Bags
KZE
Injector, Fluid, Non-Electrically Powered
LBI
Unit, Neonatal Phototherapy
LDR
Controller, Infusion, Intravascular, Electronic
LGM
Chamber, Patient Isolation
LGN
Chamber, Patient Transport Isolation
LGZ
Warmer, Thermal, Infusion Fluid
LHF
Warmer, Microwave, Infusion Fluid
LHI
Set, I.V. Fluid Transfer
LJL
Detectors And Removers, Lice, (Including Combs)
LJS
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
LJT
Port & Catheter, Implanted, Subcutaneous, Intravascular
LLI
Bed, Therapeutic, Ac-Powered, Adjustable Home-Use
LLK
Legging, Compression, Non-Inflatable
LZH
Pump, Infusion, Enteral
MDR
Binder, Medical, Therapeutic
MEA
Pump, Infusion, Pca
MEB
Pump, Infusion, Elastomeric
MEG
Syringe, Antistick
MHC
Needle, Interosseous
MHD
Pump, Infusion, Gallstone Dissolution
MJF
Check Valve, Retrograde Flow (In-Line)
MMK
Container, Sharps
MQX
Needle, Acupuncture, Single Use
MRZ
Accessories, Pump, Infusion
MZR
Topical Approximation System
NEP
System/Device, Pharmacy Compounding
NGT
Saline, Vascular Access Flush
NKK
Needle, Hypodermic, Single Lumen, Reprocessed
NKN
Syringe, Piston, Reprocessed
NRW
Stimulator, Intramuscular, Automatic
NSC
Injector, Pen
NTC
Nursing Pad, Hydrogel
NTX
Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)
NXH
Nursing Pad, Cohesive Gel
NZG
Bassinet, Hospital
NZW
Heparin, Vascular Access Flush
NZX
Water, Vascular Access Flush
OBK
Port, Protector/Cushion
ODI
Administration Set Docking Station
ODY
Tunneled Catheter Remover
OJA
Intravenous Extension Tubing Set
OKC
Implanted Subcutaneous Securement Catheter
OKE
Port Introducer Kit
OKL
Intravascular Administration Set, Automated Air Removal System
OMF
Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position
ONB
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
ONM
Radiant Infant Warmer Cabinet
PUK
Administration Set Securement Device
OPP
Pump, Infusion, Insulin Bolus
OSI
Bariatric Bed
OUW
Infant Positioner, Rx, Use In Highly Monitored Setting
OWL
Peripheral Catheter Insertion Kit
PDH
Blanket, Neonatal Phototherapy
PEF
Heparin Flush In 0.45% Sodium Chloride
PEZ
Central Venous Catheter Dressing Change Kit
PHC
Infusion Safety Management Software
PKP
Immunoglobulin G (Igg) Infusion System
PMS
Peripheral Intravenous (Piv) Infiltration Monitor
PND
Midline Catheter
POQ
Blood Transfusion Kit
POR
Parenteral Administration Kit
PQH
Iodinated Contrast Media Transfer Tubing Set
PQX
Epinephrine Syringe
PRN
Pediatric Position Holder
PTD
Subcutaneous Implanted Apheresis Port
PTI
Non-Coring (Huber) Needle
PUN
Lice Removal Kit Containing A Solution
PUR
Vacuum Syringe
PVZ
Non-Stainless Steel Needle
PWH
Administrations Sets With Neuraxial Connectors
PWN
Baby Care Kit
PWO
Blood Administration Kit
PWQ
Buret Administration Intravenous Kit
PWR
Catheter Repair Kit
PWX
Insect Sting Emergency Kit
PWY
Lumbar Puncture Tray (Adult & Pediatric)
PXB
Percutaneous Introducer Kit
PXI
Thoracentesis Tray
PXJ
Umbilical Catheter Insertion Tray
PXK
Vascular Access Port Kit
PXL
Venipuncture Kit
PYR
Neuraxial Administration Set - Intrathecal Delivery
PZW
Catheter Access Cover, Tamper-Resistant
QBL
Piston Syringe Lever
QDM
Midazolam Syringe
QEH
Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact
QJY
Infusion Pump, Drug Specific, Pharmacy-Filled
QLF
On-Body Injector
QLY
Ophthalmic Syringe
QMT
Prep Kit – Vaccine Injection
QNQ
Low Dead Space Piston Syringe
QNS
Low Dead Space Needle, Single Lumen, Hypodermic
QOG
Injection Data Capture Device
QOI
Intravenous Catheter Force-Activated Separation Device.
QTI
Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device
QYM
Ophthalmic Needle
SCL
Allergen And Vaccine Delivery Needles
SEF
Central Venous Catheter With Manual Insertion System
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—General Hospital and Personal Use Miscellaneous Devices
Subpart G—Miscellaneous Devices
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
HO
/
subpart-f—general-hospital-and-personal-use-therapeutic-devices
/
FMG
/
K872066
View Source
STERICAP STOPCOCK
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K872066
510(k) Type
Traditional
Applicant
STERICAP SYSTEMS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/4/1987
Days to Decision
67 days