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
GCI
Laryngoscope, Endoscope
2
Product Code
GCJ
Laparoscope, General & Plastic Surgery
2
Product Code
K
24
2927
Suction Irrigation Tubing Set
2
Cleared 510(K)
K
24
0831
MultiCut Solo
2
Cleared 510(K)
K
24
0334
LAGIS Endoscopic Instruments - Grasper (DI-5670-33D, DI-5670-45D, DI-5716-33D, DI-5716-45D, DI-5719-33D, DI-5731-33D, DI-5731-45D, DI-5901-33D, DI-5901-45D)
2
Cleared 510(K)
K
24
2513
FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K)
2
Cleared 510(K)
K
24
1796
TroCare TroKit Laparoscope Lens Wiper (CP000626)
2
Cleared 510(K)
K
24
1052
Bladeless Trocar; Bladed Trocar; Hasson Trocar
2
Cleared 510(K)
K
24
1913
da Vinci Handheld Camera
2
Cleared 510(K)
K
24
1401
Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control
2
Cleared 510(K)
K
24
1402
Medical Monitor (32HR734S)
2
Cleared 510(K)
K
24
1530
Stellar Imaging System
2
Cleared 510(K)
Show All 1382 Submissions
MFJ
Device, Endoscopic Suturing
2
Product Code
EPY
Speculum, Ent
1
Product Code
NAY
System, Surgical, Computer Controlled Instrument
2
Product Code
NEQ
Device, Telemedicine, Robotic
2
Product Code
PDT
Burn Resuscitation Decision Support Software
2
Product Code
FDP
Apparatus, Pneumoperitoneum, Automatic
2
Product Code
GCG
Peritoneoscope
2
Product Code
GCH
Mediastinoscope, Diagnostic
2
Product Code
OTJ
Laparoscopic Single Port Access Device
2
Product Code
OWN
Confocal Optical Imaging
2
Product Code
QGY
Mobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera
2
Product Code
NQQ
System, Imaging, Optical Coherence Tomography (Oct)
2
Product Code
POY
Post Breast Biopsy Hemostatic Breast Compression Device
2
Product Code
FXE
Speculum, Non-Illuminated
1
Product Code
FXF
Speculum, Illuminated
1
Product Code
FXG
Specula Accessories
1
Product Code
JYK
Holder, Ear Speculum
1
Product Code
KAG
Holder, Speculum, Ent
1
Product Code
QSM
System, Surgical, Computer Controlled Instrument, Remanufactured
2
Product Code
QZB
Software Controlled Endoscope And Instrument Holder
2
Product Code
Subpart C—General Hospital and Personal Use Monitoring Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
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 6 December 2024 at 11:05 pm
SU
/
subpart-b—diagnostic-devices
/
GCJ
/
K240831
View Source
MultiCut Solo
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K240831
510(k) Type
Special
Applicant
Asclepion Laser Technologies GmbH
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
11/6/2024
Days to Decision
225 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
GCI
Laryngoscope, Endoscope
GCJ
Laparoscope, General & Plastic Surgery
K
24
2927
Suction Irrigation Tubing Set
K
24
0831
MultiCut Solo
K
24
0334
LAGIS Endoscopic Instruments - Grasper (DI-5670-33D, DI-5670-45D, DI-5716-33D, DI-5716-45D, DI-5719-33D, DI-5731-33D, DI-5731-45D, DI-5901-33D, DI-5901-45D)
K
24
2513
FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K)
K
24
1796
TroCare TroKit Laparoscope Lens Wiper (CP000626)
K
24
1052
Bladeless Trocar; Bladed Trocar; Hasson Trocar
K
24
1913
da Vinci Handheld Camera
K
24
1401
Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control
K
24
1402
Medical Monitor (32HR734S)
K
24
1530
Stellar Imaging System
Show All 1382 Submissions
MFJ
Device, Endoscopic Suturing
EPY
Speculum, Ent
NAY
System, Surgical, Computer Controlled Instrument
NEQ
Device, Telemedicine, Robotic
PDT
Burn Resuscitation Decision Support Software
FDP
Apparatus, Pneumoperitoneum, Automatic
GCG
Peritoneoscope
GCH
Mediastinoscope, Diagnostic
OTJ
Laparoscopic Single Port Access Device
OWN
Confocal Optical Imaging
QGY
Mobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera
NQQ
System, Imaging, Optical Coherence Tomography (Oct)
POY
Post Breast Biopsy Hemostatic Breast Compression Device
FXE
Speculum, Non-Illuminated
FXF
Speculum, Illuminated
FXG
Specula Accessories
JYK
Holder, Ear Speculum
KAG
Holder, Speculum, Ent
QSM
System, Surgical, Computer Controlled Instrument, Remanufactured
QZB
Software Controlled Endoscope And Instrument Holder
Subpart C—General Hospital and Personal Use Monitoring Devices
Subpart D—Prosthetic Devices
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-b—diagnostic-devices
/
GCJ
/
K240831
View Source
MultiCut Solo
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K240831
510(k) Type
Special
Applicant
Asclepion Laser Technologies GmbH
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
11/6/2024
Days to Decision
225 days
Submission Type
Summary