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
- 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
- K182664FiXcision1Cleared 510(K)
- K950267URETHRAL SUTURE GUIDE1Cleared 510(K)
- K932465LI VASECTOMY1Cleared 510(K)
- K921546VASOVASOSTOMY SET1Cleared 510(K)
- K931181VESITEC SUTURE PASSER1Cleared 510(K)
- K921304DDV LIGATOR1Cleared 510(K)
- K922971NO-SCALPEL VASCETOMY INSTRUMENTS1Cleared 510(K)
- K921228BENDEREV PROTECT-A-PASS NEEDLE1Cleared 510(K)
- K922192VAS DILATOR1Cleared 510(K)
- K896058GRASPING FORCEPS1Cleared 510(K)
- K891352MARLOW ANAL SPECULUM1Cleared 510(K)
- K890218MICROSURGICAL CYSTOTOME1Cleared 510(K)
- K864963STOMACH EVACULATOR - EWALD STYLE1Cleared 510(K)
- K863273MARTIN MEDICAL PRO-SCOPE ANOSCOPE1Cleared 510(K)
- K852014EFFNER SIMS RECTAL SPECULUM W/FIBER OPTIC ILLUMINA1Cleared 510(K)
- K852726ALLIS TISSUE FORCEPS, 4X5 TEETH, 6+SS 410 OR 4201Cleared 510(K)
- K852725BABCOCK TISSUE FORCEPS, 6-1/4 + SS 410 OR 4201Cleared 510(K)
- K851162AL ASKARI PERCUTANEOUS ACCESS NEEDLE HOLDER1Cleared 510(K)
- K851111RANDALL KIDNEY STONE FORCEPS 817-84 PCS. HALF CURV1Cleared 510(K)
- K851113RANDALL KIDNEY STONE FORCEPS 817-144 PCS. FULL CUR1Cleared 510(K)
- K851112RANDALL KIDNEY STONE FORCEPS 817-144 PCS. QUARTER1Cleared 510(K)
- K841387WESTON RECTAL SNARE1Cleared 510(K)
- K834171OP-CON SURG. INSTRUMENT #31Cleared 510(K)
- K834191JAKOBI SURGICAL INSTRUMENTS #3 17/18/191Cleared 510(K)
- K834192JAKOBI SURG. INSTRUMENTS #3 21/22/241Cleared 510(K)
- K841003PROBES, VARIOUS1Cleared 510(K)
- K832677P-S MEDICAL BERLIN VISADUCT KIT1Cleared 510(K)
- K830786DISIMETRIC RELEASE OF INSTRANETICS RAD1Cleared 510(K)
- K822401ST. MARK'S RECTAL BIOPSY FORCEPS1Cleared 510(K)
- K820015URETHAL CUTTER CLAMP1Cleared 510(K)
- K813504ACESSORY TO MODIFIED FREEDING JEJUNOSTO1Cleared 510(K)
- K811973FORDER RETRACTOR1Cleared 510(K)
- K811693FORDER RETRACTOR1Cleared 510(K)
- K811223VASOVASOSTOMY STABILIZER PLATFORM DEV1Cleared 510(K)
- K810915THE SCOTT DIALMENZENSERT1Cleared 510(K)
- K810533CIRCLE NEPHROSTOMY TUBE INTRODUCER1Cleared 510(K)
- K802983THE INQUINAL RESORVOIR INSERTER1Cleared 510(K)
- K801273MAGILL CATHETER INTRO. FORCEPS1Cleared 510(K)
- K800441RUDD-CLINIC HEMORRHOIDAL FORCEPS1Cleared 510(K)
- K772134SYRINGE, IRRIGATION, PRE-FILLED1Cleared 510(K)
- K761229ANAL/RECTAL SYRINGE1Cleared 510(K)
- K760715FLEXIBLE CUTTING SCISSORS1Cleared 510(K)
- K760717FLEXIBLE BIOPSY FORCEPS1Cleared 510(K)
- K760716FLEXIBLE FOREIGN BODY FORCEPS1Cleared 510(K)
- 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
PROBES, VARIOUS
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K841003
- 510(k) Type
- Traditional
- Applicant
- PREMIER DENTAL PRODUCTS CO.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/20/1984
- Days to Decision
- 11 days