Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- GCILaryngoscope, Endoscope2Product Code
- K021747DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTOR2Cleared 510(K)
- K003222MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER2Cleared 510(K)
- K001362KARL STORZ 3D VIDEO SYSTEM2Cleared 510(K)
- K933515BOOTY ENDOSCOPE WARMER2Cleared 510(K)
- K930302BIRTCHER SURE CLEAN INSTRUMENT SYSTEM2Cleared 510(K)
- K930496GI-1090,1095,1080,1085,1086,1088, ENDO. CLAMPS2Cleared 510(K)
- K922123AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH2Cleared 510(K)
- K920139GLEESON CLOT-BUSTER2Cleared 510(K)
- K915762POOLE TIP SUCTION PROBE2Cleared 510(K)
- K914120SINGLE USE LAPAROSCOPY ELECTROSURGICAL INSTRUMENT2Cleared 510(K)
- K911829ENDOSTAPLE2Cleared 510(K)
- K911461SURGITRON2Cleared 510(K)
- K905117ENDOSCOPE AND ACCESSORIES2Cleared 510(K)
- K896205MONOSCOPY BRAND, 5 MM LOCKING TROCAR SLEEVE2Cleared 510(K)
- GCJLaparoscope, General & Plastic Surgery2Product Code
- MFJDevice, Endoscopic Suturing2Product Code
- EPYSpeculum, Ent1Product Code
- NAYSystem, Surgical, Computer Controlled Instrument2Product Code
- NEQDevice, Telemedicine, Robotic2Product Code
- PDTBurn Resuscitation Decision Support Software2Product Code
- FDPApparatus, Pneumoperitoneum, Automatic2Product Code
- GCGPeritoneoscope2Product Code
- GCHMediastinoscope, Diagnostic2Product Code
- OTJLaparoscopic Single Port Access Device2Product Code
- OWNConfocal Optical Imaging2Product Code
- QGYMobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera2Product Code
- NQQSystem, Imaging, Optical Coherence Tomography (Oct)2Product Code
- POYPost Breast Biopsy Hemostatic Breast Compression Device2Product Code
- FXESpeculum, Non-Illuminated1Product Code
- FXFSpeculum, Illuminated1Product Code
- FXGSpecula Accessories1Product Code
- JYKHolder, Ear Speculum1Product Code
- KAGHolder, Speculum, Ent1Product Code
- QSMSystem, Surgical, Computer Controlled Instrument, Remanufactured2Product Code
- QZBSoftware Controlled Endoscope And Instrument Holder2Product Code
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
SURGITRON
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K911461
- 510(k) Type
- Traditional
- Applicant
- ELLMAN INTL. MFG., INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/25/1991
- Days to Decision
- 22 days