Zinnanti Surgical Instruments, Inc.
Mchenry, IL, US
Zinnanti Surgical Instruments, Inc. appears in FDA device records in Mchenry, IL. FDA records list 76 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 76
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 76FDA records hold 76 510(k) clearances for Zinnanti Surgical Instruments, Inc. between 1984 and 1997. The busiest year on record is 1989, with 60. The most recent is 1997, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 1 |
| 1987 | 2 |
| 1988 | 1 |
| 1989 | 60 |
| 1990 | 1 |
| 1993 | 3 |
| 1994 | 5 |
| 1995 | 2 |
| 1997 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K925501 | NYLON COATED SPECULA | HIB | Substantially Equivalent | |
| K941458 | UTERINE MANIPULATOR/INJECTOR WITH SPRING | LKF | Substantially Equivalent | |
| K941457 | UTERINE INJECTOR WITH SPRING | LKF | Substantially Equivalent | |
| K925560 | ZSI LOOP, ZSI BALL & ZSI NEEDLE ELECTRODES | HGI | Substantially Equivalent | |
| K925960 | FORCEPS FOR LAPAROSCOPIC SURGERY OB/GYN USE | HFI | Substantially Equivalent | |
| K925957 | SCISSORS FOR LAPAROSCOPIC SURGERY OB/GYN USE | HFI | Substantially Equivalent | |
| K926021 | NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-OB/GYN USE | HET | Substantially Equivalent | |
| K925958 | SCISSOR FOR LAPAROSCOPIC SURGERY GU USE | GCJ | Substantially Equivalent | |
| K926181 | ZSI LAPAROSCOPES-GENERAL & PLASTIC SURGERY | GCJ | Substantially Equivalent | |
| K926016 | NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-GU USE | GCJ | Substantially Equivalent | |
| K925959 | FORCEPS FOR LAPAROSCOPIC SURGERY GU USE | GCJ | Substantially Equivalent | |
| K902975 | TWIN BALLOON INJECTOR | LKF | Substantially Equivalent | |
| K894957 | DISPOSABLE PLASTIC VAGINAL SPECULA | HIB | Substantially Equivalent | |
| K892252 | BIOPSY FORCEPS | FCL | Substantially Equivalent | |
| K894201 | GOMCO CIRCUMCISION CLAMP | HFX | Substantially Equivalent | |
| K892691 | CATHETERS, MALE, FEMALE | KOD | Substantially Equivalent | |
| K892687 | CANNULATED BIOPSY FORCEPS | EOQ | Substantially Equivalent | |
| K892259 | JESBERG ESOPHAGOSCOPE | EOX | Substantially Equivalent | |
| K892549 | SUCTION TUBES: HOUSE, BARON | GCX | Substantially Equivalent | |
| K892693 | VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT | KOH | Substantially Equivalent | |
| K892546 | TAYLOR SPINAL RETRACTOR | HAO | Substantially Equivalent | |
| K892535 | NEUROLOGICAL RONGEURS - VARIOUS TYPES | HAE | Substantially Equivalent | |
| K891398 | RETRACTOR RODS | KNA | Substantially Equivalent | |
| K892261 | RUBBER DAM CLAMPS/FORCEPS | EKJ | Substantially Equivalent | |
| K892550 | BEST COLON CLAMP | FFN | Substantially Equivalent | |
| K892542 | RECTAL SPECULA - CHELSEA-EATON, KELLY, MATHIEU | FFN | Substantially Equivalent | |
| K892543 | NEUROSURICAL RETRACTORS - VARIOUS TYPES | GZT | Substantially Equivalent | |
| K892531 | NEUROSURGICAL DRILLS: STILLE, HUDSON | HBG | Substantially Equivalent | |
| K892260 | PRICHARD PERIOSTEAL RETRACTOR #3 | EKJ | Substantially Equivalent | |
| K892255 | DENTAL ROOT ELEVATOR | EKO | Substantially Equivalent | |
| K891902 | CHISELS- FREER, LUCAS, ALEXANDER, BISHOP | KGD | Substantially Equivalent | |
| K891901 | GOUGES, ALEXANDER, BISHOP, LUCAS | GDH | Substantially Equivalent | |
| K891899 | ELEVATORS, VARIOUS TYPES | GEG | Substantially Equivalent | |
| K891898 | SKIN HOOKS, VARIOUS TYPES | GDG | Substantially Equivalent | |
| K891896 | TISSUE FORCEPS, VARIOUS TYPES | GEN | Substantially Equivalent | |
| K891895 | SURGICAL LOUPES | FSP | Substantially Equivalent | |
| K891894 | ELEVATORS-COTTLE,MCKENTY,GOLDMAN,JOSEPH,CONVERSE | GEG | Substantially Equivalent | |
| K891892 | ROLLET RETRACTOR | GAD | Substantially Equivalent | |
| K891889 | OLIVECORONA SCISSORS | LRW | Substantially Equivalent | |
| K891888 | CURRETTES - PIFFARD, WOLF, VIDAL-SCRAPER | FZS | Substantially Equivalent | |
| K891887 | OSTEOTOMES, VARIOUS TYPES | GFI | Substantially Equivalent | |
| K891886 | SCISSORS, VARIOUS TYPES | LRW | Substantially Equivalent | |
| K891401 | HEMOSTATIC FORCEPS BRUNS.,GEMINI,SPENCER-WELL,KANT | GEN | Substantially Equivalent | |
| K891400 | MICRO CAUTERY NEEDLES | JOS | Substantially Equivalent | |
| K891203 | SCISSORS: THOREK, JORGENSEN, FINOCHIETTO | LRW | Substantially Equivalent | |
| K891200 | RIBBON TYPE SCISSORS: TENOTOMY,IRIS,EYE,STRABISMUS | LRW | Substantially Equivalent | |
| K891031 | KIRSCHNER RETRACTOR | GAD | Substantially Equivalent | |
| K891402 | UTERINE CLAMPS | HGC | Substantially Equivalent | |
| K891399 | CORSON MYOMA GRASPING FORCEPS | KNA | Substantially Equivalent | |
| K891397 | GREENE-ARMYTAGE HEMOSTATIC FORCEPS | KNA | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered
- EOQBronchoscope (Flexible Or Rigid)
- EKJBurnisher, Operative
- LKFCannula, Manipulator/Injector, Uterine
- KODCatheter, Urological
- HFXClamp, Circumcision
- FFNClamp, Non-Electrical
- HGCClamp, Uterine
- HFICoagulator, Culdoscopic (And Accessories)
- HHKCurette, Suction, Endometrial (And Accessories)
- FZSCurette, Surgical, General Use
- EKODenture Preformed (Partially Prefabricated Denture)
- HDQDilator, Cervical, Fixed Size
- HBGDrills, Burrs, Trephines & Accessories (Manual)
- HGIElectrocautery, Gynecologic (And Accessories)
- JOSElectrode, Electrosurgical
- GEGElevator, Surgical, General & Plastic Surgery
- HDPElevator, Uterine
- EOXEsophagoscope (Flexible Or Rigid)
- HFBForceps, Biopsy, Gynecological
- FCLForceps, Biopsy, Non-Electric
- GENForceps, General & Plastic Surgery
- HCZForceps, Surgical, Gynecological
- GDHGouge, Surgical, General & Plastic Surgery
- GDGHook, Surgical, General & Plastic Surgery
- HIHHysteroscope (And Accessories)
- KOHInstrument, Manual, General Obstetric-Gynecologic
- KNAInstrument, Manual, Specialized Obstetric-Gynecologic
- HAOInstrument, Surgical, Non-Powered
- HESInsufflator, Carbon-Dioxide, Uterotubal (And Accessories)
- HIGInsufflator, Hysteroscopic
- GCJLaparoscope, General & Plastic Surgery
- HETLaparoscope, Gynecologic (And Accessories)
- FSPLoupe, Diagnostic/Surgical
- GFIOsteotome, Manual
- HHFRemover, Intrauterine Device, Contraceptive, Hook-Type
- GADRetractor
- GZTRetractor, Self-Retaining, For Neurosurgery
- HDLRetractor, Vaginal
- HAERongeur, Manual
- KGDScissors For Cystoscope
- LRWScissors, General, Surgical
- HHTSpatula, Cervical, Cytological
- HDFSpeculum, Vaginal, Metal
- HIBSpeculum, Vaginal, Nonmetal
- HDCTenaculum, Uterine
- HFDWasher, Endometrial
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain
