FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
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
Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—General Hospital and Personal Use Monitoring Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
ESF
Polymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent
2
Product Code
EZX
Mesh, Surgical, Metal
2
Product Code
MIB
Elastomer, Silicone Block
2
Product Code
K
22
3051
Pre-Formed Silicone Block
2
Cleared 510(K)
K
22
2748
ShiNeo Silicone Implant
2
Cleared 510(K)
K
20
0073
AugMENTA Penile Implant
2
Cleared 510(K)
K
22
0760
Pre-Formed Penile Silicone Block
2
Cleared 510(K)
K
19
3392
BioSiCar Silicone Implant
2
Cleared 510(K)
K
18
1387
Pre-Formed Penile Silicone Block
2
Cleared 510(K)
K
17
1851
SOFTXIL
2
Cleared 510(K)
K
16
2624
Pre-Formed Penile Silicone Block
2
Cleared 510(K)
K
05
2504
GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X
2
Cleared 510(K)
K
05
2505
CALF IMPLANT, MODEL EC17-X
2
Cleared 510(K)
K
04
2054
SILIMED PECTORAL IMPLANT
2
Cleared 510(K)
K
04
2380
SILICONE BLOCK
2
Cleared 510(K)
K
04
0042
MEDISIL SILICONE SHEETING
2
Cleared 510(K)
K
03
0808
HANSON MEDICAL CALF IMPLANT
2
Cleared 510(K)
K
03
0809
HANSON MEDICAL GLUTEAL IMPLANT
2
Cleared 510(K)
K
02
2511
AART CALF IMPLANT
2
Cleared 510(K)
K
02
2223
AART SILICONE SHEETING
2
Cleared 510(K)
K
02
1820
AART SILICONE CARVING BLOCK
2
Cleared 510(K)
K
02
1839
AART GLUTEAL IMPLANT
2
Cleared 510(K)
K
98
3630
SEARE BIOMEDICAL SILICONE RODS
2
Cleared 510(K)
K
98
2688
SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK
2
Cleared 510(K)
K
98
3041
SEARE BIOMEDICAL SILICONE SHEETING
2
Cleared 510(K)
K
98
2065
STERILE SILICONE EXTERNAL WOUND COVER
2
Cleared 510(K)
K
98
1851
SILIMED SILICONE CARVING BLOCK
2
Cleared 510(K)
K
97
4653
SILICONE ELASTOMER SHEETING
2
Cleared 510(K)
K
97
4654
SILICONE BLOCKS
2
Cleared 510(K)
K
97
4482
SILIMED GLUTEAL IMPLANT
2
Cleared 510(K)
K
97
4480
SILIMED CALF IMPLANT
2
Cleared 510(K)
K
97
3730
DURASIL I AND DURASIL II
2
Cleared 510(K)
K
97
3166
DOW CORNING SILASTIC ELASTOMER Q7-4750
2
Cleared 510(K)
K
97
3728
SILICONE CARVING BLOCK
2
Cleared 510(K)
K
97
1480
DURALASTIC I AND DURALASTIC II
2
Cleared 510(K)
K
97
1613
SIL-TEC SMALL/LARGE BORE TUBING/SIL-TEC HIGH DUROMETER TUBING/SIL-TEC RADIOPAQUE TUBING
2
Cleared 510(K)
K
96
1081
SPIRIT RIDGE SILICONE CARVING BLOCK
2
Cleared 510(K)
K
96
1057
DURALASTIC SHEETING II
2
Cleared 510(K)
K
96
0038
SPECTRUM DESIGNS SILICONE BLOCK
2
Cleared 510(K)
K
95
5370
DURALASTIC II
2
Cleared 510(K)
K
95
5368
DURALASTIC I
2
Cleared 510(K)
K
95
4382
PROLASTIC SHEETING
2
Cleared 510(K)
K
95
2732
MEDICAL GRADE SILICONE BLOCK
2
Cleared 510(K)
K
94
5552
DURALASTIC SHEETING
2
Cleared 510(K)
K
93
5571
DURALASTIC SHEETING
2
Cleared 510(K)
K
94
4408
IMPLANTECH MEDICAL GRADE SILICONE SHEETING
2
Cleared 510(K)
K
91
3882
ZARA SILICONE BLOCK
2
Cleared 510(K)
MIC
Implant, Muscle, Pectoralis
2
Product Code
BTX
Board, Arm (With Cover), Sterile
1
Product Code
FTL
Mesh, Surgical, Polymeric
2
Product Code
FTM
Mesh, Surgical
2
Product Code
FTN
Plastic Surgery And Accessories Kit
1
Product Code
FTR
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
3
Product Code
FWM
Prosthesis, Breast, Inflatable, Internal, Saline
3
Product Code
FWP
Prosthesis, Chin, Internal
2
Product Code
FYI
Appliance, Facial Fracture, External
1
Product Code
FZD
Prosthesis, Ear, Internal
2
Product Code
FZE
Prosthesis, Nose, Internal
2
Product Code
FZF
Splint, Extremity, Inflatable, External
1
Product Code
GBI
Material, External Aesthetic Restoration, Used With Adhesive
1
Product Code
GBJ
Prosthesis, Adhesive, External
1
Product Code
JCQ
Prosthesis, Esophagus
2
Product Code
KCZ
Prosthesis, Breast, External, Used With Adhesive
1
Product Code
KDA
Prosthesis, Ptfe/Carbon-Fiber
2
Product Code
KKY
Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
2
Product Code
LZK
Implant, Malar
2
Product Code
MCA
Tape, Surgical, Internal
2
Product Code
MNF
Implant, Temporal
2
Product Code
NOC
Splint, Extremity, Non-Inflatable, External, Non-Sterile
1
Product Code
NOD
Board, Arm (With Cover), Non-Sterile
1
Product Code
NOJ
Prosthesis, Breast, External, No Adhesive
1
Product Code
NOK
Material, External Aesthetic Restoration, No Adhesive
1
Product Code
NWA
Prosthesis, Tracheal, Preformed/Molded
2
Product Code
NYT
Prosthesis, Tracheal, Expandable, Polymeric
2
Product Code
ODU
Facial Implant
2
Product Code
OXG
Mesh, Surgical, Non-Absorbable, Plastic And Reconstructive Surgery
2
Product Code
OOD
Surgical Film
2
Product Code
OQL
Mesh, Surgical, Deployment Balloon
2
Product Code
ORQ
Mesh, Surgical, Deployer
2
Product Code
OWR
Mesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery
2
Product Code
OWS
Mesh, Surgical, Collagen, Plastics, Facial Implants
2
Product Code
OWT
Mesh, Surgical, Absorbable, Abdominal Hernia
2
Product Code
OWU
Mesh, Surgical, Non-Absorbable, Diaphragmatic Hernia
2
Product Code
OWV
Mesh, Surgical, Collagen, Diaphragmatic Hernia
2
Product Code
OWW
Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
2
Product Code
OWX
Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon
2
Product Code
OWY
Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
2
Product Code
OWZ
Mesh, Surgical, Absorbable, Thoracic, Chest Wall Reconstruction
2
Product Code
OXA
Mesh, Surgical, Non-Absorbable, Thoracic, Chest Wall Reconstruction
2
Product Code
OXB
Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction
2
Product Code
OXC
Mesh, Surgical, Absorbable, Staple Line Reinforcement
2
Product Code
OXD
Mesh, Surgical, Non-Absorbable, Staple Line Reinforcement
2
Product Code
OXE
Mesh, Surgical, Collagen, Staple Line Reinforcement
2
Product Code
OXF
Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
2
Product Code
OXH
Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
2
Product Code
OXI
Mesh, Surgical, Absorbable, Large Abdominal Wall Defects
2
Product Code
OXJ
Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects
2
Product Code
OXK
Mesh, Surgical, Collagen, Large Abdominal Wall Defects
2
Product Code
OXL
Mesh, Surgical, Absorbable, Organ Support
2
Product Code
OXM
Mesh, Surgical, Absorbable, Fistula
2
Product Code
OXN
Mesh, Surgical, Collagen, Fistula
2
Product Code
PIJ
Collagen Surgical Mesh Containing Drugs
2
Product Code
PQN
Carbon Dioxide Gas Controlled Tissue Expander
2
Product Code
Subpart E—Neurological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 16 August 2024 at 11:05 pm
SU
/
subpart-d—prosthetic-devices
/
MIB
/
K973728
View Source
SILICONE CARVING BLOCK
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K973728
510(k) Type
Traditional
Applicant
HANSON MEDICAL, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/13/1997
Days to Decision
44 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Miscellaneous
Subpart B—Diagnostic Devices
Subpart C—General Hospital and Personal Use Monitoring Devices
Subpart D—Prosthetic Devices
ESF
Polymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent
EZX
Mesh, Surgical, Metal
MIB
Elastomer, Silicone Block
K
22
3051
Pre-Formed Silicone Block
K
22
2748
ShiNeo Silicone Implant
K
20
0073
AugMENTA Penile Implant
K
22
0760
Pre-Formed Penile Silicone Block
K
19
3392
BioSiCar Silicone Implant
K
18
1387
Pre-Formed Penile Silicone Block
K
17
1851
SOFTXIL
K
16
2624
Pre-Formed Penile Silicone Block
K
05
2504
GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X
K
05
2505
CALF IMPLANT, MODEL EC17-X
K
04
2054
SILIMED PECTORAL IMPLANT
K
04
2380
SILICONE BLOCK
K
04
0042
MEDISIL SILICONE SHEETING
K
03
0808
HANSON MEDICAL CALF IMPLANT
K
03
0809
HANSON MEDICAL GLUTEAL IMPLANT
K
02
2511
AART CALF IMPLANT
K
02
2223
AART SILICONE SHEETING
K
02
1820
AART SILICONE CARVING BLOCK
K
02
1839
AART GLUTEAL IMPLANT
K
98
3630
SEARE BIOMEDICAL SILICONE RODS
K
98
2688
SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK
K
98
3041
SEARE BIOMEDICAL SILICONE SHEETING
K
98
2065
STERILE SILICONE EXTERNAL WOUND COVER
K
98
1851
SILIMED SILICONE CARVING BLOCK
K
97
4653
SILICONE ELASTOMER SHEETING
K
97
4654
SILICONE BLOCKS
K
97
4482
SILIMED GLUTEAL IMPLANT
K
97
4480
SILIMED CALF IMPLANT
K
97
3730
DURASIL I AND DURASIL II
K
97
3166
DOW CORNING SILASTIC ELASTOMER Q7-4750
K
97
3728
SILICONE CARVING BLOCK
K
97
1480
DURALASTIC I AND DURALASTIC II
K
97
1613
SIL-TEC SMALL/LARGE BORE TUBING/SIL-TEC HIGH DUROMETER TUBING/SIL-TEC RADIOPAQUE TUBING
K
96
1081
SPIRIT RIDGE SILICONE CARVING BLOCK
K
96
1057
DURALASTIC SHEETING II
K
96
0038
SPECTRUM DESIGNS SILICONE BLOCK
K
95
5370
DURALASTIC II
K
95
5368
DURALASTIC I
K
95
4382
PROLASTIC SHEETING
K
95
2732
MEDICAL GRADE SILICONE BLOCK
K
94
5552
DURALASTIC SHEETING
K
93
5571
DURALASTIC SHEETING
K
94
4408
IMPLANTECH MEDICAL GRADE SILICONE SHEETING
K
91
3882
ZARA SILICONE BLOCK
MIC
Implant, Muscle, Pectoralis
BTX
Board, Arm (With Cover), Sterile
FTL
Mesh, Surgical, Polymeric
FTM
Mesh, Surgical
FTN
Plastic Surgery And Accessories Kit
FTR
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FWM
Prosthesis, Breast, Inflatable, Internal, Saline
FWP
Prosthesis, Chin, Internal
FYI
Appliance, Facial Fracture, External
FZD
Prosthesis, Ear, Internal
FZE
Prosthesis, Nose, Internal
FZF
Splint, Extremity, Inflatable, External
GBI
Material, External Aesthetic Restoration, Used With Adhesive
GBJ
Prosthesis, Adhesive, External
JCQ
Prosthesis, Esophagus
KCZ
Prosthesis, Breast, External, Used With Adhesive
KDA
Prosthesis, Ptfe/Carbon-Fiber
KKY
Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
LZK
Implant, Malar
MCA
Tape, Surgical, Internal
MNF
Implant, Temporal
NOC
Splint, Extremity, Non-Inflatable, External, Non-Sterile
NOD
Board, Arm (With Cover), Non-Sterile
NOJ
Prosthesis, Breast, External, No Adhesive
NOK
Material, External Aesthetic Restoration, No Adhesive
NWA
Prosthesis, Tracheal, Preformed/Molded
NYT
Prosthesis, Tracheal, Expandable, Polymeric
ODU
Facial Implant
OXG
Mesh, Surgical, Non-Absorbable, Plastic And Reconstructive Surgery
OOD
Surgical Film
OQL
Mesh, Surgical, Deployment Balloon
ORQ
Mesh, Surgical, Deployer
OWR
Mesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery
OWS
Mesh, Surgical, Collagen, Plastics, Facial Implants
OWT
Mesh, Surgical, Absorbable, Abdominal Hernia
OWU
Mesh, Surgical, Non-Absorbable, Diaphragmatic Hernia
OWV
Mesh, Surgical, Collagen, Diaphragmatic Hernia
OWW
Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
OWX
Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon
OWY
Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
OWZ
Mesh, Surgical, Absorbable, Thoracic, Chest Wall Reconstruction
OXA
Mesh, Surgical, Non-Absorbable, Thoracic, Chest Wall Reconstruction
OXB
Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction
OXC
Mesh, Surgical, Absorbable, Staple Line Reinforcement
OXD
Mesh, Surgical, Non-Absorbable, Staple Line Reinforcement
OXE
Mesh, Surgical, Collagen, Staple Line Reinforcement
OXF
Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
OXH
Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
OXI
Mesh, Surgical, Absorbable, Large Abdominal Wall Defects
OXJ
Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects
OXK
Mesh, Surgical, Collagen, Large Abdominal Wall Defects
OXL
Mesh, Surgical, Absorbable, Organ Support
OXM
Mesh, Surgical, Absorbable, Fistula
OXN
Mesh, Surgical, Collagen, Fistula
PIJ
Collagen Surgical Mesh Containing Drugs
PQN
Carbon Dioxide Gas Controlled Tissue Expander
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Toxicology
Medical Genetics
Unknown
SU
/
subpart-d—prosthetic-devices
/
MIB
/
K973728
View Source
SILICONE CARVING BLOCK
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K973728
510(k) Type
Traditional
Applicant
HANSON MEDICAL, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/13/1997
Days to Decision
44 days
Submission Type
Summary