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Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart B—Obstetrical and Gynecological Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart C—Monitoring Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Obstetrical and Gynecological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
FAD
Stent, Ureteral
2
Product Code
EXX
Probe, Rectal, Non-Powered
1
Product Code
EYD
Stirrups
1
Product Code
EYH
Table, Cysto, Non-Electrical
1
Product Code
EYS
Ribdam
1
Product Code
EZO
Urethrotome
2
Product Code
EZP
Rod, Colostomy
2
Product Code
FAR
Unit, Electrosurgical
2
Product Code
FAS
Electrode, Electrosurgical, Active, Urological
2
Product Code
FBJ
Cord, Electric For Transurethral Surgical Instrument
2
Product Code
FBS
Sound, Metal, Interconnected
1
Product Code
FCH
Tray, Biopsy, Without Biopsy Instruments
1
Product Code
FCS
Light, Catheter, Fiberoptic, Glass, Ureteral
2
Product Code
FDB
Plate, Patient
2
Product Code
FDG
Retractor, Fiberoptic
1
Product Code
FDI
Snare, Flexible
2
Product Code
FDJ
Snare, Rigid Self-Opening
2
Product Code
FDL
Wristlet, Patient Return
2
Product Code
FEH
Electrode, Flexible Suction Coagulator
2
Product Code
FEO
Lithotriptor, Ultrasonic
2
Product Code
FFD
Evacuator, Bladder, Manually Operated
1
Product Code
FFE
System, Water Jet Catheter, Renal
2
Product Code
FFI
System, Alarm, Electrosurgical
2
Product Code
FFK
Lithotriptor, Electro-Hydraulic
2
Product Code
FFL
Dislodger, Stone, Basket, Ureteral, Metal
2
Product Code
FFN
Clamp, Non-Electrical
1
Product Code
FFO
Retractor, Self-Retaining
1
Product Code
FFQ
Speculum, Rectal
1
Product Code
FFR
Device, Locking, For Intestinal Clamp
1
Product Code
FGK
Tripsor, Stone, Bladder
2
Product Code
FGM
Probe And Director, Gastro-Urology
1
Product Code
FGN
Retractor, Non-Self-Retaining
1
Product Code
FGO
Dislodger, Stone, Flexible
2
Product Code
FGW
Clamp, Electrical
2
Product Code
FGX
Snare, Non-Electrical
1
Product Code
FHB
Hook, Gastro-Urology
1
Product Code
FHC
Adaptor To The Cord, For Transurethral Surgical Instrument
2
Product Code
FHF
System, Evacuator, Fluid
2
Product Code
FHH
Crusher, Spur, Colostomy
1
Product Code
FHI
Ring, Laparotomy
1
Product Code
FHK
Spreader, Bladder Neck
1
Product Code
FHL
Scoop
1
Product Code
FHN
Ligator, Hemorrhoidal
2
Product Code
FHQ
Holder, Needle, Gastroenterologic
1
Product Code
FHY
Jelly, Contact, For Transurethral Surgical Instrument
2
Product Code
FHZ
Desiccator, Transurethral
2
Product Code
FKK
Clamp, Line
1
Product Code
KGE
Forceps, Biopsy, Electric
2
Product Code
KNS
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
2
Product Code
KOA
Surgical Instruments, G-U, Manual (And Accessories)
1
Product Code
K
18
2664
FiXcision
1
Cleared 510(K)
K
95
0267
URETHRAL SUTURE GUIDE
1
Cleared 510(K)
K
93
2465
LI VASECTOMY
1
Cleared 510(K)
K
92
1546
VASOVASOSTOMY SET
1
Cleared 510(K)
K
93
1181
VESITEC SUTURE PASSER
1
Cleared 510(K)
K
92
1304
DDV LIGATOR
1
Cleared 510(K)
K
92
2971
NO-SCALPEL VASCETOMY INSTRUMENTS
1
Cleared 510(K)
K
92
1228
BENDEREV PROTECT-A-PASS NEEDLE
1
Cleared 510(K)
K
92
2192
VAS DILATOR
1
Cleared 510(K)
K
89
6058
GRASPING FORCEPS
1
Cleared 510(K)
K
89
1352
MARLOW ANAL SPECULUM
1
Cleared 510(K)
K
89
0218
MICROSURGICAL CYSTOTOME
1
Cleared 510(K)
K
86
4963
STOMACH EVACULATOR - EWALD STYLE
1
Cleared 510(K)
K
86
3273
MARTIN MEDICAL PRO-SCOPE ANOSCOPE
1
Cleared 510(K)
K
85
2014
EFFNER SIMS RECTAL SPECULUM W/FIBER OPTIC ILLUMINA
1
Cleared 510(K)
K
85
2726
ALLIS TISSUE FORCEPS, 4X5 TEETH, 6+SS 410 OR 420
1
Cleared 510(K)
K
85
2725
BABCOCK TISSUE FORCEPS, 6-1/4 + SS 410 OR 420
1
Cleared 510(K)
K
85
1162
AL ASKARI PERCUTANEOUS ACCESS NEEDLE HOLDER
1
Cleared 510(K)
K
85
1112
RANDALL KIDNEY STONE FORCEPS 817-144 PCS. QUARTER
1
Cleared 510(K)
K
85
1113
RANDALL KIDNEY STONE FORCEPS 817-144 PCS. FULL CUR
1
Cleared 510(K)
K
85
1111
RANDALL KIDNEY STONE FORCEPS 817-84 PCS. HALF CURV
1
Cleared 510(K)
K
84
1387
WESTON RECTAL SNARE
1
Cleared 510(K)
K
83
4171
OP-CON SURG. INSTRUMENT #3
1
Cleared 510(K)
K
83
4192
JAKOBI SURG. INSTRUMENTS #3 21/22/24
1
Cleared 510(K)
K
83
4191
JAKOBI SURGICAL INSTRUMENTS #3 17/18/19
1
Cleared 510(K)
K
84
1003
PROBES, VARIOUS
1
Cleared 510(K)
K
83
2677
P-S MEDICAL BERLIN VISADUCT KIT
1
Cleared 510(K)
K
83
0786
DISIMETRIC RELEASE OF INSTRANETICS RAD
1
Cleared 510(K)
K
82
2401
ST. MARK'S RECTAL BIOPSY FORCEPS
1
Cleared 510(K)
K
82
0015
URETHAL CUTTER CLAMP
1
Cleared 510(K)
K
81
3504
ACESSORY TO MODIFIED FREEDING JEJUNOSTO
1
Cleared 510(K)
K
81
1973
FORDER RETRACTOR
1
Cleared 510(K)
K
81
1693
FORDER RETRACTOR
1
Cleared 510(K)
K
81
1223
VASOVASOSTOMY STABILIZER PLATFORM DEV
1
Cleared 510(K)
K
81
0915
THE SCOTT DIALMENZENSERT
1
Cleared 510(K)
K
81
0533
CIRCLE NEPHROSTOMY TUBE INTRODUCER
1
Cleared 510(K)
K
80
2983
THE INQUINAL RESORVOIR INSERTER
1
Cleared 510(K)
K
80
1273
MAGILL CATHETER INTRO. FORCEPS
1
Cleared 510(K)
K
80
0441
RUDD-CLINIC HEMORRHOIDAL FORCEPS
1
Cleared 510(K)
K
77
2134
SYRINGE, IRRIGATION, PRE-FILLED
1
Cleared 510(K)
K
76
1229
ANAL/RECTAL SYRINGE
1
Cleared 510(K)
K
76
0715
FLEXIBLE CUTTING SCISSORS
1
Cleared 510(K)
K
76
0717
FLEXIBLE BIOPSY FORCEPS
1
Cleared 510(K)
K
76
0716
FLEXIBLE FOREIGN BODY FORCEPS
1
Cleared 510(K)
KQS
Table, Cystometric, Non-Electric And Accessories
1
Product Code
KQT
Evacuator, Gastro-Urology
2
Product Code
LQC
Lithotriptor, Biliary Mechanical
2
Product Code
MMZ
Table, Cystometric, Electric
2
Product Code
MND
Ligator, Esophageal
2
Product Code
NLR
Unit, Electrosurgical, Endoscopic (With Or Without Accessories), Reprocessed
2
Product Code
NLT
Snare, Flexible, Reprocessed
2
Product Code
NLU
Forceps, Biopsy, Electric, Reprocessed
2
Product Code
NLV
Electrode, Flexible Suction Coagulator, Reprocessed
2
Product Code
NLW
Electrode, Electrosurgical, Active, Urological, Reprocessed
2
Product Code
NQT
Dislodger, Stone, Flexible, Ureteral, Reprocessed
2
Product Code
NQU
Dislodger, Stone, Basket, Ureteral, Metal, Reprocessed
2
Product Code
NWI
Electrosurgical Electrode Kit
2
Product Code
OLH
Orchidometer
1
Product Code
ONJ
Dissolvable Gel For Preventing Ureteral Stone Migration
2
Product Code
OOW
Applicator For Rectal Suppository
1
Product Code
PKL
Hemostatic Metal Clip For The Gi Tract
2
Product Code
PLP
High Intensity Ultrasound System For Prostate Tissue Ablation
2
Product Code
PRU
Gastric Lavage Kit (Adult Or Pediatric Use)
2
Product Code
QGB
Ureteral Stent Accessories
1
Product Code
PVY
Vasovasostomy Set
1
Product Code
QNE
Endoscopic Pancreatic Debridement Device
2
Product Code
QAG
Endoscopic Electrosurgical Clip Cutting System
2
Product Code
LNK
Laser For Gastro-Urology Use
2
Product Code
MUK
Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue
2
Product Code
NEJ
System, Cryosurgical, Liquid Nitrogen, For Gastroenterology
2
Product Code
PZP
Fluid Jet Removal 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
General Hospital
Review Panel
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 9 May 2025 at 11:05 pm
GU
/
subpart-e—surgical-devices
/
KOA
/
K813504
View Source
ACESSORY TO MODIFIED FREEDING JEJUNOSTO
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K813504
510(k) Type
Traditional
Applicant
MIDWEST METABOLIC SUPPORT GROUP
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/7/1982
Days to Decision
23 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
Miscellaneous
Subpart B—Diagnostic Devices
Subpart B—Obstetrical and Gynecological Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—Monitoring Devices
Subpart D—Prosthetic Devices
Subpart E—Obstetrical and Gynecological Surgical Devices
Subpart E—Surgical Devices
FAD
Stent, Ureteral
EXX
Probe, Rectal, Non-Powered
EYD
Stirrups
EYH
Table, Cysto, Non-Electrical
EYS
Ribdam
EZO
Urethrotome
EZP
Rod, Colostomy
FAR
Unit, Electrosurgical
FAS
Electrode, Electrosurgical, Active, Urological
FBJ
Cord, Electric For Transurethral Surgical Instrument
FBS
Sound, Metal, Interconnected
FCH
Tray, Biopsy, Without Biopsy Instruments
FCS
Light, Catheter, Fiberoptic, Glass, Ureteral
FDB
Plate, Patient
FDG
Retractor, Fiberoptic
FDI
Snare, Flexible
FDJ
Snare, Rigid Self-Opening
FDL
Wristlet, Patient Return
FEH
Electrode, Flexible Suction Coagulator
FEO
Lithotriptor, Ultrasonic
FFD
Evacuator, Bladder, Manually Operated
FFE
System, Water Jet Catheter, Renal
FFI
System, Alarm, Electrosurgical
FFK
Lithotriptor, Electro-Hydraulic
FFL
Dislodger, Stone, Basket, Ureteral, Metal
FFN
Clamp, Non-Electrical
FFO
Retractor, Self-Retaining
FFQ
Speculum, Rectal
FFR
Device, Locking, For Intestinal Clamp
FGK
Tripsor, Stone, Bladder
FGM
Probe And Director, Gastro-Urology
FGN
Retractor, Non-Self-Retaining
FGO
Dislodger, Stone, Flexible
FGW
Clamp, Electrical
FGX
Snare, Non-Electrical
FHB
Hook, Gastro-Urology
FHC
Adaptor To The Cord, For Transurethral Surgical Instrument
FHF
System, Evacuator, Fluid
FHH
Crusher, Spur, Colostomy
FHI
Ring, Laparotomy
FHK
Spreader, Bladder Neck
FHL
Scoop
FHN
Ligator, Hemorrhoidal
FHQ
Holder, Needle, Gastroenterologic
FHY
Jelly, Contact, For Transurethral Surgical Instrument
FHZ
Desiccator, Transurethral
FKK
Clamp, Line
KGE
Forceps, Biopsy, Electric
KNS
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
KOA
Surgical Instruments, G-U, Manual (And Accessories)
K
18
2664
FiXcision
K
95
0267
URETHRAL SUTURE GUIDE
K
93
2465
LI VASECTOMY
K
92
1546
VASOVASOSTOMY SET
K
93
1181
VESITEC SUTURE PASSER
K
92
1304
DDV LIGATOR
K
92
2971
NO-SCALPEL VASCETOMY INSTRUMENTS
K
92
1228
BENDEREV PROTECT-A-PASS NEEDLE
K
92
2192
VAS DILATOR
K
89
6058
GRASPING FORCEPS
K
89
1352
MARLOW ANAL SPECULUM
K
89
0218
MICROSURGICAL CYSTOTOME
K
86
4963
STOMACH EVACULATOR - EWALD STYLE
K
86
3273
MARTIN MEDICAL PRO-SCOPE ANOSCOPE
K
85
2014
EFFNER SIMS RECTAL SPECULUM W/FIBER OPTIC ILLUMINA
K
85
2726
ALLIS TISSUE FORCEPS, 4X5 TEETH, 6+SS 410 OR 420
K
85
2725
BABCOCK TISSUE FORCEPS, 6-1/4 + SS 410 OR 420
K
85
1162
AL ASKARI PERCUTANEOUS ACCESS NEEDLE HOLDER
K
85
1112
RANDALL KIDNEY STONE FORCEPS 817-144 PCS. QUARTER
K
85
1113
RANDALL KIDNEY STONE FORCEPS 817-144 PCS. FULL CUR
K
85
1111
RANDALL KIDNEY STONE FORCEPS 817-84 PCS. HALF CURV
K
84
1387
WESTON RECTAL SNARE
K
83
4171
OP-CON SURG. INSTRUMENT #3
K
83
4192
JAKOBI SURG. INSTRUMENTS #3 21/22/24
K
83
4191
JAKOBI SURGICAL INSTRUMENTS #3 17/18/19
K
84
1003
PROBES, VARIOUS
K
83
2677
P-S MEDICAL BERLIN VISADUCT KIT
K
83
0786
DISIMETRIC RELEASE OF INSTRANETICS RAD
K
82
2401
ST. MARK'S RECTAL BIOPSY FORCEPS
K
82
0015
URETHAL CUTTER CLAMP
K
81
3504
ACESSORY TO MODIFIED FREEDING JEJUNOSTO
K
81
1973
FORDER RETRACTOR
K
81
1693
FORDER RETRACTOR
K
81
1223
VASOVASOSTOMY STABILIZER PLATFORM DEV
K
81
0915
THE SCOTT DIALMENZENSERT
K
81
0533
CIRCLE NEPHROSTOMY TUBE INTRODUCER
K
80
2983
THE INQUINAL RESORVOIR INSERTER
K
80
1273
MAGILL CATHETER INTRO. FORCEPS
K
80
0441
RUDD-CLINIC HEMORRHOIDAL FORCEPS
K
77
2134
SYRINGE, IRRIGATION, PRE-FILLED
K
76
1229
ANAL/RECTAL SYRINGE
K
76
0715
FLEXIBLE CUTTING SCISSORS
K
76
0717
FLEXIBLE BIOPSY FORCEPS
K
76
0716
FLEXIBLE FOREIGN BODY FORCEPS
KQS
Table, Cystometric, Non-Electric And Accessories
KQT
Evacuator, Gastro-Urology
LQC
Lithotriptor, Biliary Mechanical
MMZ
Table, Cystometric, Electric
MND
Ligator, Esophageal
NLR
Unit, Electrosurgical, Endoscopic (With Or Without Accessories), Reprocessed
NLT
Snare, Flexible, Reprocessed
NLU
Forceps, Biopsy, Electric, Reprocessed
NLV
Electrode, Flexible Suction Coagulator, Reprocessed
NLW
Electrode, Electrosurgical, Active, Urological, Reprocessed
NQT
Dislodger, Stone, Flexible, Ureteral, Reprocessed
NQU
Dislodger, Stone, Basket, Ureteral, Metal, Reprocessed
NWI
Electrosurgical Electrode Kit
OLH
Orchidometer
ONJ
Dissolvable Gel For Preventing Ureteral Stone Migration
OOW
Applicator For Rectal Suppository
PKL
Hemostatic Metal Clip For The Gi Tract
PLP
High Intensity Ultrasound System For Prostate Tissue Ablation
PRU
Gastric Lavage Kit (Adult Or Pediatric Use)
QGB
Ureteral Stent Accessories
PVY
Vasovasostomy Set
QNE
Endoscopic Pancreatic Debridement Device
QAG
Endoscopic Electrosurgical Clip Cutting System
LNK
Laser For Gastro-Urology Use
MUK
Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue
NEJ
System, Cryosurgical, Liquid Nitrogen, For Gastroenterology
PZP
Fluid Jet Removal 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
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
GU
/
subpart-e—surgical-devices
/
KOA
/
K813504
View Source
ACESSORY TO MODIFIED FREEDING JEJUNOSTO
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K813504
510(k) Type
Traditional
Applicant
MIDWEST METABOLIC SUPPORT GROUP
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/7/1982
Days to Decision
23 days