Zinnanti Surgical Instruments, Inc.: FDA clearances and approvals
Zinnanti Surgical Instruments, Inc. has 76 FDA 510(k) clearances (first 1984, latest 1997), across 47 product codes in 7 review panels. Median 510(k) review time: 23 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KNA | Instrument, Manual, Specialized Obstetric-Gynecologic | 9 | 9 |
| GCJ | Laparoscope, General & Plastic Surgery | 4 | 4 |
| LRW | Scissors, General, Surgical | 4 | 4 |
| HFB | Forceps, Biopsy, Gynecological | 3 | 3 |
| KOH | Instrument, Manual, General Obstetric-Gynecologic | 3 | 3 |
| LKF | Cannula, Manipulator/Injector, Uterine | 3 | 3 |
| EKJ | Burnisher, Operative | 2 | 2 |
| FFN | Clamp, Non-Electrical | 2 | 2 |
| GAD | Retractor | 2 | 2 |
| GEG | Elevator, Surgical, General & Plastic Surgery | 2 | 2 |
Plus 37 more product codes.
Review panels
- Obstetrics and Gynecology (41)
- General and Plastic Surgery (20)
- Gastroenterology and Urology (5)
- Neurology (4)
- Dental (3)
- Ear, Nose and Throat (2)
- General Hospital (1)
Most recent Zinnanti Surgical Instruments, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K925501 | NYLON COATED SPECULA | HIB | 1997-06-13 | 1687 |
| K941458 | UTERINE MANIPULATOR/INJECTOR WITH SPRING | LKF | 1995-01-25 | 306 |
| K941457 | UTERINE INJECTOR WITH SPRING | LKF | 1995-01-24 | 305 |
| K925560 | ZSI LOOP, ZSI BALL & ZSI NEEDLE ELECTRODES | HGI | 1994-08-30 | 665 |
| K925960 | FORCEPS FOR LAPAROSCOPIC SURGERY OB/GYN USE | HFI | 1994-06-07 | 560 |
| K925957 | SCISSORS FOR LAPAROSCOPIC SURGERY OB/GYN USE | HFI | 1994-06-07 | 560 |
| K926021 | NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-OB/GYN USE | HET | 1994-04-07 | 493 |
| K925958 | SCISSOR FOR LAPAROSCOPIC SURGERY GU USE | GCJ | 1994-03-24 | 485 |
| K926181 | ZSI LAPAROSCOPES-GENERAL & PLASTIC SURGERY | GCJ | 1993-12-17 | 374 |
| K926016 | NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-GU USE | GCJ | 1993-11-12 | 347 |
66 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Zinnanti Surgical Instruments, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Zinnanti Surgical Instruments, Inc. have?
Zinnanti Surgical Instruments, Inc. has 76 FDA 510(k) clearances (first 1984, latest 1997), across 47 product codes in 7 review panels.
How long does FDA take to clear Zinnanti Surgical Instruments, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Zinnanti Surgical Instruments, Inc.'s cleared 510(k)s is 23 days.
What devices does Zinnanti Surgical Instruments, Inc. make?
Its most frequent FDA product codes are KNA (Instrument, Manual, Specialized Obstetric-Gynecologic, 9); GCJ (Laparoscope, General & Plastic Surgery, 4); LRW (Scissors, General, Surgical, 4).
Has Zinnanti Surgical Instruments, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Zinnanti Surgical Instruments, Inc. Related entities may recall under other names.
Next steps
- See all 76 Zinnanti Surgical Instruments, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KNA, Zinnanti Surgical Instruments, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.