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
- MiscellaneousMiscellaneous
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Obstetrical and Gynecological Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart D—Obstetrical and Gynecological Prosthetic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- HERPelvimeter, External1Product Code
- FHGBell, Circumcision2Product Code
- FHJShield, Circumcision2Product Code
- HCYCurette, Uterine1Product Code
- HCZForceps, Surgical, Gynecological2Product Code
- HDAForceps, Obstetrical2Product Code
- HDBExtractor, Vacuum, Fetal2Product Code
- HDCTenaculum, Uterine2Product Code
- HDDTable, Obstetrical, Ac-Powered (And Accessories)2Product Code
- HDEHook, Fibroid, Gynecological1Product Code
- HDFSpeculum, Vaginal, Metal1Product Code
- HDGSpeculum, Vaginal, Metal, Fiberoptic1Product Code
- HDHNeedle, Cerclage, Gynecological1Product Code
- HDIHook, Destructive, Obstetrical2Product Code
- HDJScissors, Umbilical1Product Code
- HDKScissors, Episiotomy1Product Code
- HDLRetractor, Vaginal1Product Code
- HDMPacker, Uterine1Product Code
- HDNDilator, Cervical, Expandable3Product Code
- HDPElevator, Uterine2Product Code
- HDQDilator, Cervical, Fixed Size1Product Code
- HDYDilator, Cervical, Hygroscopic-Laminaria2Product Code
- HDZKnife, Cervical Cone2Product Code
- HFBForceps, Biopsy, Gynecological1Product Code
- HFGCoagulator, Laparoscopic, Unipolar (And Accessories)2Product Code
- HFHCoagulator, Hysteroscopic (And Accessories)2Product Code
- HFICoagulator, Culdoscopic (And Accessories)2Product Code
- HFWClamp, Umbilical2Product Code
- HFXClamp, Circumcision2Product Code
- HFZCraniotribe2Product Code
- HGACranioclast2Product Code
- HGCClamp, Uterine1Product Code
- HGDApplicator, Vaginal1Product Code
- HGEAmniotome1Product Code
- HGIElectrocautery, Gynecologic (And Accessories)2Product Code
- K202915IRIS Thermocoagulator and Digital Colposcope2Cleared 510(K)
- K152843Liger Medical HTU-1102Cleared 510(K)
- K130606FMWAND FERROMAGNETIC SURGICAL SYSTEM2Cleared 510(K)
- K121881DOMAIN SURGICAL SYSTEM2Cleared 510(K)
- K070877ENDOCERVICAL ELECTRODE # 22Cleared 510(K)
- K061651FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 1582Cleared 510(K)
- K022593THOMAS MEDICAL ELECTRODES2Cleared 510(K)
- K003608SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY2Cleared 510(K)
- K002042TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 2330182Cleared 510(K)
- K993527LOOP ELECTRODE, BALL ELECTRODE2Cleared 510(K)
- K993777DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES2Cleared 510(K)
- K983840WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED)2Cleared 510(K)
- K982739GYNEX ELECTRODES2Cleared 510(K)
- K974138ROCKET ELECTRODE2Cleared 510(K)
- K971986VALLEY FORGE BIPOLAR LOOP2Cleared 510(K)
- K965245TBD2Cleared 510(K)
- K963653WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM2Cleared 510(K)
- K963348WALLACH INTEGRATION UNIT2Cleared 510(K)
- K963852KSEA THERMOCOAGULATOR (MODEL 265100 20)2Cleared 510(K)
- K955756KARL STORZ POINT COAGULATOR, SEMM CROCODILE FORCEPS, MYOMA ENUCLEATOR2Cleared 510(K)
- K961460LWEET CONE BIOPSY INSTRUMENT2Cleared 510(K)
- K952030LOOP/SQUARE ELECTRODE2Cleared 510(K)
- K955093ASPIRATION/COAGULATION ELECTRODE ACE-311 & ACE-5112Cleared 510(K)
- K952483LEEP SYSTEM 10002Cleared 510(K)
- K944450SURGI-LINK LLETZ NEEDLE ELECTRODE, LOOP ELECTRODE, SQUARE LOOP ELECTRODE2Cleared 510(K)
- K921791WALLACH LEAP 100 ELECTRO SURGERY SYSTEM2Cleared 510(K)
- K942986ELECTRODES (BLADE, BALL, NEEDLE, AND LOOP)2Cleared 510(K)
- K940191ELECTROSURGICAL LOOP ELECTRODE2Cleared 510(K)
- K941251FINESSE IEC/6012Cleared 510(K)
- K925333SINGLE USE TUNGSTEN WIRE LEE LOOP ELECTRODE2Cleared 510(K)
- K925560ZSI LOOP, ZSI BALL & ZSI NEEDLE ELECTRODES2Cleared 510(K)
- K935634WALLACH LEEP PROCEDURE KIT2Cleared 510(K)
- K925478ELECTROSURGICAL ELECTRODE2Cleared 510(K)
- K931541MODEL 26-0375, ELECTROSURGICAL GENERATOR2Cleared 510(K)
- K931437MODEL 80-1983, ELECTROSURGICAL GENERATOR2Cleared 510(K)
- K930132LEEP AND LLETZ ELECTRODES2Cleared 510(K)
- K926179SEDLACEK HANDLE2Cleared 510(K)
- K923570CRYOMEDICS LLETZ LOOPS2Cleared 510(K)
- K923628CERVICAL LOOP ELECTRODE & ROLLERBALL ELECTRODE2Cleared 510(K)
- K93133816 ELECTRODES (BLADE, BALL, NEEDLE & LOOP)2Cleared 510(K)
- K921386SUOP ELECTRODES FOR EXCISIONAL PROCEDURES2Cleared 510(K)
- K922206SURGISTAT2Cleared 510(K)
- K921884FORCE 22Cleared 510(K)
- K921222FORCE 1C2Cleared 510(K)
- K914367ELECTROSURGICAL GENERATOR MODEL ESU100/250/5502Cleared 510(K)
- K914329SURGITRON UNITS- ELECTRO SURG SYST GYN INDICATION2Cleared 510(K)
- K912046SINGLE USE LEE ELECTRODE2Cleared 510(K)
- K913213SINGLE USE LEE ELECTRODE2Cleared 510(K)
- K905263UTAH ESSU2Cleared 510(K)
- K905747LEEP SYSTEM 6000 ELECTROSURGICAL UNIT AND ACCESSOR2Cleared 510(K)
- K895402ENDOCOAGULATOR 2001 KLI2Cleared 510(K)
- K770295ABDOMINAL ECG PROCESSOR FOR FETAL MONI.2Cleared 510(K)
- K770292MONITOR, FETAL HEART, MODEL 19802Cleared 510(K)
- HHFRemover, Intrauterine Device, Contraceptive, Hook-Type1Product Code
- HHGDilator, Cervical, Vibratory3Product Code
- HHMSound, Uterine1Product Code
- HHNCleidoclast2Product Code
- HHOScrew, Fibroid, Gynecological2Product Code
- HHPTable, Obstetrical, Manual (And Accessories)2Product Code
- HHRLaser, Surgical, Gynecologic2Product Code
- HHTSpatula, Cervical, Cytological2Product Code
- HIBSpeculum, Vaginal, Nonmetal2Product Code
- HICSpeculum, Vaginal, Nonmetal, Fiberoptic2Product Code
- HIMElectrocautery, Endoscopic And Accessories2Product Code
- HINCoagulator-Cutter, Endoscopic, Bipolar (And Accessories)2Product Code
- KNAInstrument, Manual, Specialized Obstetric-Gynecologic2Product Code
- KNBInstrument, Destructive, Fetal, Obstetric2Product Code
- KNCTable, Obstetric (And Accessories)2Product Code
- KNFCoagulator-Cutter, Endoscopic, Unipolar (And Accessories)2Product Code
- KOHInstrument, Manual, General Obstetric-Gynecologic1Product Code
- LBXPelvimeter, Internal2Product Code
- LKFCannula, Manipulator/Injector, Uterine2Product Code
- LLWLaser, Neodymium:Yag For Gynecologic Use2Product Code
- MDGSystem, Intrafallopian Cannula2Product Code
- MLSLabor And Delivery Kit2Product Code
- MLTPelvic Exam Kit2Product Code
- MOVCatheters, Salpingography2Product Code
- MPUSource, Chemiluminescent Light2Product Code
- NBZClamp And Cutter, Umbilical2Product Code
- NMGForceps, Biopsy, Gynecological, Reprocessed2Product Code
- OHCObstetrical Vacuum Delivery Kit2Product Code
- PBQFixation, Non-Absorbable Or Absorbable, For Pelvic Use2Product Code
- OHGCircumcision Tray2Product Code
- PFJCatheter, Balloon, Dilation Of Cervical Canal Prior To Labor2Product Code
- OHLPap Smear Kit2Product Code
- OJFHysterectomy Kit2Product Code
- PGKCannula, Injector, Uterine, Endometrial Biopsy2Product Code
- PKNDilator, Cervical, Synthetic, Osmotic2Product Code
- OKUEmergency Obstetrical Kit1Product Code
- OKVObstetrical Kit2Product Code
- OKYCytology Kit2Product Code
- OQYIntrauterine Tamponade Balloon2Product Code
- PMUContainment System, Laparoscopic Power Morcellation, With Instrument Port2Product Code
- PONCatheter, Balloon, Dilation Of Cervical Canal2Product Code
- PUATenaculum, Uterine, Exempt2Product Code
- PVRD&C Tray2Product Code
- PVXVaginal Examination Tray2Product Code
- PWBFetal Head Elevator2Product Code
- PWIInstrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse2Product Code
- PWKInstrumentation, Surgical Mesh, Urogynecologic, Transabdominal Repair Of Pelvic Organ Prolapse2Product Code
- Subpart F—Obstetrical and Gynecological Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—Assisted Reproduction DevicesCFR Sub-Part
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
WALLACH INTEGRATION UNIT
- Page Type
- Cleared 510(K)
- 510(k) Number
- K963348
- 510(k) Type
- Traditional
- Applicant
- WALLACH SURGICAL DEVICES, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/19/1997
- Days to Decision
- 205 days
- Submission Type
- Statement