Anesthesiology
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- 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
- 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
- K251562OTSCneo System Set (100.03n-14n, 100.27n-31n)2Cleared 510(K)
- K252271Hemoclip2Cleared 510(K)
- K250229Dual Action Tissue Closure Device2Cleared 510(K)
- K250842PADLOCK CLIP EFTR Kit (00713229)2Cleared 510(K)
- K250066Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Resolution Clip (M00522611); Resolution Clip (M00522612)2Cleared 510(K)
- K241005Haemostasis Clips2Cleared 510(K)
- K240274PADLOCK CLIP EFTR Kit (00713229)2Cleared 510(K)
- K241858BARS Set (100.60)2Cleared 510(K)
- K234124Single Use Hemoclips2Cleared 510(K)
- K232969Disposable Hemostatic Clips2Cleared 510(K)
- K240617Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)2Cleared 510(K)
- K233772Disposable Dual Action Tissue Closure Device2Cleared 510(K)
- K232450Disposable Hemostatic Clips2Cleared 510(K)
- K231633Disposable Hemoclip (AF series)2Cleared 510(K)
- K230004Disposable Hemoclip2Cleared 510(K)
- K222146Disposable Endoscopic Hemoclip2Cleared 510(K)
- K213217Disposable hemoclip2Cleared 510(K)
- K222503Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip2Cleared 510(K)
- K221124MANTIS Clip2Cleared 510(K)
- K213143Hemoclip2Cleared 510(K)
- K213338CORE-CLIP2Cleared 510(K)
- K220157Disposable Hemostatic Closure Clip Device2Cleared 510(K)
- K212669Single Use Hemoclip2Cleared 510(K)
- K211787Hemoclip2Cleared 510(K)
- K212748Disposable Dual Action Tissue Clip2Cleared 510(K)
- K212323Instinct Plus Endoscopic Clipping Device2Cleared 510(K)
- K202333Lockado Repositionable Hemostasis Clip2Cleared 510(K)
- K201808X-Tack Endoscopic HeliX Tacking System2Cleared 510(K)
- K201771Single Use Rotatable and Repositionable Hemoclip2Cleared 510(K)
- K200217ClearEndoclip2Cleared 510(K)
- K193424Resolution 360™ ULTRA Clip2Cleared 510(K)
- K200684gastroduodenal FTRD Set2Cleared 510(K)
- K192697Instinct Plus Endoscopic Clipping Device2Cleared 510(K)
- K192722Padlock Clip defect closure system, Padlock Pro-Select defect closure device2Cleared 510(K)
- K183309stentfix OTSC System Set2Cleared 510(K)
- K183590Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super Short Clip2Cleared 510(K)
- K183021ClearEndoclip2Cleared 510(K)
- K182556SureClip Repositionable Hemostasis Clip2Cleared 510(K)
- K180325Single Use MultiClip Device2Cleared 510(K)
- K172727Hemoclip2Cleared 510(K)
- K180689Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device2Cleared 510(K)
- K172762Single Use Hemoclip2Cleared 510(K)
- K170867FTRD System Set2Cleared 510(K)
- K161463SureClip(TM) Repositionable Hemostasis Clip2Cleared 510(K)
- K153550FTRD System Set2Cleared 510(K)
- K152001Sterile Repositionable Hemostasis Clipping Device2Cleared 510(K)
- K150067OTSC Proctology2Cleared 510(K)
- K151802Resolution Clip2Cleared 510(K)
- K142973Resolution Clip2Cleared 510(K)
- K132809INSTINCT ENDOSCOPIC HEMOCLIP2Cleared 510(K)
- K123601SINGLE USE REPOSITIONABLE CLIP2Cleared 510(K)
- K122660RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611, M005226122Cleared 510(K)
- K120814PADLOCK CLIP-122Cleared 510(K)
- K121505DISPOSABLE HEMOSTASIS CHIP2Cleared 510(K)
- K102764RESOLUTION II CLIP2Cleared 510(K)
- K101428OTSC (OVER-THE SCOPE-CLIP) SYSTEM SET2Cleared 510(K)
- K023903WILSON-COOK ENDOSCOPIC CLIPPING DEVICE2Cleared 510(K)
- K013889ENDOSCOPIC MULTI-FIRE CLIP APPLIER2Cleared 510(K)
- K990687HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE, ENDOSCOPIC CLIPS2Cleared 510(K)
- K963160HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE2Cleared 510(K)
- 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
X-Tack Endoscopic HeliX Tacking System
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K201808
- 510(k) Type
- Traditional
- Applicant
- Apollo Endosurgery, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/15/2020
- Days to Decision
- 167 days
- Submission Type
- Summary