Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- FADStent, Ureteral2Product Code
- EXXProbe, Rectal, Non-Powered1Product Code
- EYDStirrups1Product Code
- EYHTable, Cysto, Non-Electrical1Product Code
- EYSRibdam1Product Code
- EZOUrethrotome2Product Code
- EZPRod, Colostomy2Product Code
- FARUnit, Electrosurgical2Product Code
- FASElectrode, Electrosurgical, Active, Urological2Product Code
- FBJCord, Electric For Transurethral Surgical Instrument2Product Code
- FBSSound, Metal, Interconnected1Product Code
- FCHTray, Biopsy, Without Biopsy Instruments1Product Code
- FCSLight, Catheter, Fiberoptic, Glass, Ureteral2Product Code
- FDBPlate, Patient2Product Code
- FDGRetractor, Fiberoptic1Product Code
- FDISnare, Flexible2Product Code
- K221713Polypectomy Snare2Cleared 510(K)
- K220846CORE-SNARE2Cleared 510(K)
- K220089Disposable Polyp Snare2Cleared 510(K)
- K220790Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare2Cleared 510(K)
- K213222Disposable Polypectomy Snare2Cleared 510(K)
- K212860SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit)2Cleared 510(K)
- K202478Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares2Cleared 510(K)
- K200745Lariat, Hot/Cold Snare2Cleared 510(K)
- K190512SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare2Cleared 510(K)
- K191048AcuSnare Polypectomy Snare - Duckbill2Cleared 510(K)
- K183289ClearGrasp Snare2Cleared 510(K)
- K182909Roth Net Retriever Product Line2Cleared 510(K)
- K173673AcuSnare Polypectomy Snare2Cleared 510(K)
- K172729Polypectomy Snare2Cleared 510(K)
- K172758Rotatable Snares, Non-Rotatable Snares2Cleared 510(K)
- K172734Single Use Electrosurgical Snare SD-4002Cleared 510(K)
- K160637Rotatable Snares2Cleared 510(K)
- K152580rescuenet2Cleared 510(K)
- K150316Polypectomy Snare2Cleared 510(K)
- K151197Lariat snare2Cleared 510(K)
- K140923TRACTION POLYPECTOMY SNARE2Cleared 510(K)
- K142258PolyCatch Retrieval Device2Cleared 510(K)
- K140726CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 1, CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 5, CAPTIV2Cleared 510(K)
- K140763MONOFILAMENT POLYPECTOMY SNARE2Cleared 510(K)
- K133987CAPTIVATOR II,SINGLE-USE POLYPECTOMY SNARES2Cleared 510(K)
- K133513MULTI-STAGE SNARE2Cleared 510(K)
- K131700SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE, SINGLE-USE POLYPECTOMY SNARES2Cleared 510(K)
- K123223EC SINGLE USE, POLYPECTOMY SNARE2Cleared 510(K)
- K122462ROTH NET RETRIEVER2Cleared 510(K)
- K103611UROLOGY MONOPOLAR SNARE FOR TISSUE TRANSECTION2Cleared 510(K)
- K091355DEUCE POLYPECTOMY SNARE, MODELS 000995, 000996,000997, 0009982Cleared 510(K)
- K083049TORNADO ROTATABEL SNARE AND POLYP CATCHER2Cleared 510(K)
- K073288ETHICON ENDO SURGERY ARTICULATING SNARE2Cleared 510(K)
- K050294COOK IRELAND SONNET POLYPECTOMY SNARE2Cleared 510(K)
- K040961INJECTOR NEEDLE/SNARE2Cleared 510(K)
- K022268HORIZONS REUSABLE POLYPECTOMY SNARES2Cleared 510(K)
- K020891NAKAO SNARE II AND NAKAO SNARE III2Cleared 510(K)
- K011667HORIZONS INTERNATIONAL POLYPECTOMY SNARES2Cleared 510(K)
- K002927SNARE,FLEXIBLE2Cleared 510(K)
- K992477ROTOSNARE2Cleared 510(K)
- K971275MILL-ROSE DISPOSABLE POLYPECTOMY SNARE2Cleared 510(K)
- K970356IRRIGATION/ASPIRATION POLYPECTOMY2Cleared 510(K)
- K960230SNARE2Cleared 510(K)
- K955650OLYMPUS SD SERIES SNARES2Cleared 510(K)
- K951600MILL-ROSE ROTATABLE POLYPECTOMY SNARE2Cleared 510(K)
- K943935GIP/MEDI-GLOBE POLYPECTOMY SNARES2Cleared 510(K)
- K950496SNARE, FLEXIBLE, ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES2Cleared 510(K)
- K941750PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES2Cleared 510(K)
- K942110INJECT-SNARE2Cleared 510(K)
- K940335AMERICAN CATHETER POLY-SNARE2Cleared 510(K)
- K923031ENDOSNARE2Cleared 510(K)
- K930022SPHINCTEROTOME2Cleared 510(K)
- K924105SNARE FLEXIBLE2Cleared 510(K)
- K923671COX DISPOSABLE POLYPECTOMY SNARES2Cleared 510(K)
- K912254COX DIAPOSABLE POLYPECTOMY SNARE2Cleared 510(K)
- K911482LAPAROSCOPIC SNARE2Cleared 510(K)
- K902265FLEXIBLE SNARE2Cleared 510(K)
- K901428DISPOSABLE GASTROINTESTINAL POLYPECTOMY SNARE2Cleared 510(K)
- K901322DOBBHOFF(R) POLYPECTOMY SNARE2Cleared 510(K)
- K894869WILTEK POLYPECTOMY SNARE2Cleared 510(K)
- K893553BIPOLAR ELECTROSURGICAL SNARE2Cleared 510(K)
- K845016DAVOL POLYPECTOMY SNARE2Cleared 510(K)
- FDJSnare, Rigid Self-Opening2Product Code
- FDLWristlet, Patient Return2Product Code
- FEHElectrode, Flexible Suction Coagulator2Product Code
- FEOLithotriptor, Ultrasonic2Product Code
- FFDEvacuator, Bladder, Manually Operated1Product Code
- FFESystem, Water Jet Catheter, Renal2Product Code
- FFISystem, Alarm, Electrosurgical2Product Code
- FFKLithotriptor, Electro-Hydraulic2Product Code
- FFLDislodger, Stone, Basket, Ureteral, Metal2Product Code
- FFNClamp, Non-Electrical1Product Code
- FFORetractor, Self-Retaining1Product Code
- FFQSpeculum, Rectal1Product Code
- FFRDevice, Locking, For Intestinal Clamp1Product Code
- FGKTripsor, Stone, Bladder2Product Code
- FGMProbe And Director, Gastro-Urology1Product Code
- FGNRetractor, Non-Self-Retaining1Product Code
- FGODislodger, Stone, Flexible2Product Code
- FGWClamp, Electrical2Product Code
- FGXSnare, Non-Electrical1Product Code
- FHBHook, Gastro-Urology1Product Code
- FHCAdaptor To The Cord, For Transurethral Surgical Instrument2Product Code
- FHFSystem, Evacuator, Fluid2Product Code
- FHHCrusher, Spur, Colostomy1Product Code
- FHIRing, Laparotomy1Product Code
- FHKSpreader, Bladder Neck1Product Code
- FHLScoop1Product Code
- FHNLigator, Hemorrhoidal2Product Code
- FHQHolder, Needle, Gastroenterologic1Product Code
- FHYJelly, Contact, For Transurethral Surgical Instrument2Product Code
- FHZDesiccator, Transurethral2Product Code
- FKKClamp, Line1Product Code
- KGEForceps, Biopsy, Electric2Product Code
- KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)2Product Code
- KOASurgical Instruments, G-U, Manual (And Accessories)1Product Code
- KQSTable, Cystometric, Non-Electric And Accessories1Product Code
- KQTEvacuator, Gastro-Urology2Product Code
- LQCLithotriptor, Biliary Mechanical2Product Code
- MMZTable, Cystometric, Electric2Product Code
- MNDLigator, Esophageal2Product Code
- NLRUnit, Electrosurgical, Endoscopic (With Or Without Accessories), Reprocessed2Product Code
- NLTSnare, Flexible, Reprocessed2Product Code
- NLUForceps, Biopsy, Electric, Reprocessed2Product Code
- NLVElectrode, Flexible Suction Coagulator, Reprocessed2Product Code
- NLWElectrode, Electrosurgical, Active, Urological, Reprocessed2Product Code
- NQTDislodger, Stone, Flexible, Ureteral, Reprocessed2Product Code
- NQUDislodger, Stone, Basket, Ureteral, Metal, Reprocessed2Product Code
- NWIElectrosurgical Electrode Kit2Product Code
- OLHOrchidometer1Product Code
- ONJDissolvable Gel For Preventing Ureteral Stone Migration2Product Code
- OOWApplicator For Rectal Suppository1Product Code
- PKLHemostatic Metal Clip For The Gi Tract2Product Code
- PLPHigh Intensity Ultrasound System For Prostate Tissue Ablation2Product Code
- PRUGastric Lavage Kit (Adult Or Pediatric Use)2Product Code
- QGBUreteral Stent Accessories1Product Code
- PVYVasovasostomy Set1Product Code
- QNEEndoscopic Pancreatic Debridement Device2Product Code
- QAGEndoscopic Electrosurgical Clip Cutting System2Product Code
- LNKLaser For Gastro-Urology Use2Product Code
- MUKElectrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue2Product Code
- NEJSystem, Cryosurgical, Liquid Nitrogen, For Gastroenterology2Product Code
- PZPFluid Jet Removal System2Product Code
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- 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
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Roth Net Retriever Product Line
- Page Type
- Cleared 510(K)
- 510(k) Number
- K182909
- 510(k) Type
- Special
- Applicant
- United States Endoscopy Group, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/21/2018
- Days to Decision
- 35 days
- Submission Type
- Statement