Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Zinnanti Surgical Instruments, Inc. · Predicate Candidate Screening
76 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
23 daysmedian FDA review time
353 days90th percentile
76clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K925501 | NYLON COATED SPECULA | Zinnanti Surgical Instruments, Inc. | 1997-06-13 | 1687 | 0 |
| K941458 | UTERINE MANIPULATOR/INJECTOR WITH SPRING | Zinnanti Surgical Instruments, Inc. | 1995-01-25 | 306 | 0 |
| K941457 | UTERINE INJECTOR WITH SPRING | Zinnanti Surgical Instruments, Inc. | 1995-01-24 | 305 | 0 |
| K925560 | ZSI LOOP, ZSI BALL & ZSI NEEDLE ELECTRODES | Zinnanti Surgical Instruments, Inc. | 1994-08-30 | 665 | 0 |
| K925960 | FORCEPS FOR LAPAROSCOPIC SURGERY OB/GYN USE | Zinnanti Surgical Instruments, Inc. | 1994-06-07 | 560 | 0 |
| K925957 | SCISSORS FOR LAPAROSCOPIC SURGERY OB/GYN USE | Zinnanti Surgical Instruments, Inc. | 1994-06-07 | 560 | 0 |
| K926021 | NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-OB/GYN USE | Zinnanti Surgical Instruments, Inc. | 1994-04-07 | 493 | 0 |
| K925958 | SCISSOR FOR LAPAROSCOPIC SURGERY GU USE | Zinnanti Surgical Instruments, Inc. | 1994-03-24 | 485 | 0 |
| K926181 | ZSI LAPAROSCOPES-GENERAL & PLASTIC SURGERY | Zinnanti Surgical Instruments, Inc. | 1993-12-17 | 374 | 0 |
| K926016 | NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-GU USE | Zinnanti Surgical Instruments, Inc. | 1993-11-12 | 347 | 0 |
| K925959 | FORCEPS FOR LAPAROSCOPIC SURGERY GU USE | Zinnanti Surgical Instruments, Inc. | 1993-11-12 | 353 | 0 |
| K902975 | TWIN BALLOON INJECTOR | Zinnanti Surgical Instruments, Inc. | 1990-09-26 | 82 | 0 |
| K894957 | DISPOSABLE PLASTIC VAGINAL SPECULA | Zinnanti Surgical Instruments, Inc. | 1989-10-12 | 66 | 0 |
| K892252 | BIOPSY FORCEPS | Zinnanti Surgical Instruments, Inc. | 1989-10-03 | 182 | 0 |
| K894201 | GOMCO CIRCUMCISION CLAMP | Zinnanti Surgical Instruments, Inc. | 1989-08-11 | 56 | 0 |
| K892691 | CATHETERS, MALE, FEMALE | Zinnanti Surgical Instruments, Inc. | 1989-06-23 | 71 | 0 |
| K892687 | CANNULATED BIOPSY FORCEPS | Zinnanti Surgical Instruments, Inc. | 1989-06-21 | 69 | 0 |
| K892259 | JESBERG ESOPHAGOSCOPE | Zinnanti Surgical Instruments, Inc. | 1989-06-16 | 73 | 0 |
| K892549 | SUCTION TUBES: HOUSE, BARON | Zinnanti Surgical Instruments, Inc. | 1989-05-18 | 37 | 0 |
| K892546 | TAYLOR SPINAL RETRACTOR | Zinnanti Surgical Instruments, Inc. | 1989-05-11 | 30 | 0 |
| K892535 | NEUROLOGICAL RONGEURS - VARIOUS TYPES | Zinnanti Surgical Instruments, Inc. | 1989-05-11 | 30 | 0 |
| K892693 | VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT | Zinnanti Surgical Instruments, Inc. | 1989-05-11 | 28 | 0 |
| K891398 | RETRACTOR RODS | Zinnanti Surgical Instruments, Inc. | 1989-05-11 | 58 | 0 |
| K892261 | RUBBER DAM CLAMPS/FORCEPS | Zinnanti Surgical Instruments, Inc. | 1989-05-10 | 36 | 0 |
| K892542 | RECTAL SPECULA - CHELSEA-EATON, KELLY, MATHIEU | Zinnanti Surgical Instruments, Inc. | 1989-05-09 | 28 | 0 |
| K892550 | BEST COLON CLAMP | Zinnanti Surgical Instruments, Inc. | 1989-05-09 | 28 | 0 |
| K892543 | NEUROSURICAL RETRACTORS - VARIOUS TYPES | Zinnanti Surgical Instruments, Inc. | 1989-05-05 | 24 | 0 |
| K892531 | NEUROSURGICAL DRILLS: STILLE, HUDSON | Zinnanti Surgical Instruments, Inc. | 1989-05-05 | 24 | 0 |
| K892260 | PRICHARD PERIOSTEAL RETRACTOR #3 | Zinnanti Surgical Instruments, Inc. | 1989-05-02 | 28 | 0 |
| K892255 | DENTAL ROOT ELEVATOR | Zinnanti Surgical Instruments, Inc. | 1989-05-01 | 27 | 0 |
| K891896 | TISSUE FORCEPS, VARIOUS TYPES | Zinnanti Surgical Instruments, Inc. | 1989-04-12 | 19 | 0 |
| K891895 | SURGICAL LOUPES | Zinnanti Surgical Instruments, Inc. | 1989-04-12 | 19 | 0 |
| K891889 | OLIVECORONA SCISSORS | Zinnanti Surgical Instruments, Inc. | 1989-04-12 | 19 | 0 |
| K891886 | SCISSORS, VARIOUS TYPES | Zinnanti Surgical Instruments, Inc. | 1989-04-12 | 19 | 0 |
| K891899 | ELEVATORS, VARIOUS TYPES | Zinnanti Surgical Instruments, Inc. | 1989-04-12 | 19 | 0 |
| K891894 | ELEVATORS-COTTLE,MCKENTY,GOLDMAN,JOSEPH,CONVERSE | Zinnanti Surgical Instruments, Inc. | 1989-04-12 | 19 | 0 |
| K891887 | OSTEOTOMES, VARIOUS TYPES | Zinnanti Surgical Instruments, Inc. | 1989-04-12 | 19 | 0 |
| K891892 | ROLLET RETRACTOR | Zinnanti Surgical Instruments, Inc. | 1989-04-12 | 19 | 0 |
| K891888 | CURRETTES - PIFFARD, WOLF, VIDAL-SCRAPER | Zinnanti Surgical Instruments, Inc. | 1989-04-12 | 19 | 0 |
| K891901 | GOUGES, ALEXANDER, BISHOP, LUCAS | Zinnanti Surgical Instruments, Inc. | 1989-04-12 | 19 | 0 |
| K891902 | CHISELS- FREER, LUCAS, ALEXANDER, BISHOP | Zinnanti Surgical Instruments, Inc. | 1989-04-12 | 19 | 0 |
| K891898 | SKIN HOOKS, VARIOUS TYPES | Zinnanti Surgical Instruments, Inc. | 1989-04-12 | 19 | 0 |
| K891400 | MICRO CAUTERY NEEDLES | Zinnanti Surgical Instruments, Inc. | 1989-04-06 | 23 | 0 |
| K891200 | RIBBON TYPE SCISSORS: TENOTOMY,IRIS,EYE,STRABISMUS | Zinnanti Surgical Instruments, Inc. | 1989-04-06 | 31 | 0 |
| K891031 | KIRSCHNER RETRACTOR | Zinnanti Surgical Instruments, Inc. | 1989-04-06 | 37 | 0 |
| K891203 | SCISSORS: THOREK, JORGENSEN, FINOCHIETTO | Zinnanti Surgical Instruments, Inc. | 1989-04-06 | 31 | 0 |
| K891401 | HEMOSTATIC FORCEPS BRUNS.,GEMINI,SPENCER-WELL,KANT | Zinnanti Surgical Instruments, Inc. | 1989-04-06 | 23 | 0 |
| K891397 | GREENE-ARMYTAGE HEMOSTATIC FORCEPS | Zinnanti Surgical Instruments, Inc. | 1989-03-29 | 15 | 0 |
| K891402 | UTERINE CLAMPS | Zinnanti Surgical Instruments, Inc. | 1989-03-29 | 15 | 0 |
| K891399 | CORSON MYOMA GRASPING FORCEPS | Zinnanti Surgical Instruments, Inc. | 1989-03-29 | 15 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda