Ultracision, Inc.: FDA clearances and approvals
Ultracision, Inc. has 9 FDA 510(k) clearances (first 1989, latest 1995), across 2 product codes in 1 review panel. Median 510(k) review time: 90 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 6 | 6 |
| GCJ | Laparoscope, General & Plastic Surgery | 3 | 3 |
Review panels
Most recent Ultracision, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K952726 | ULTRACISION HARMONIC SCAPEL | GEI | 1995-06-23 | 9 |
| K941897 | ULTRACISON HARMONIC SCALPEL HS2 BLADE | GEI | 1994-07-01 | 74 |
| K930352 | HARMONIC SCALPEL REUSABLE LAPORASCOPIC BLADE SYST. | GCJ | 1993-06-08 | 138 |
| K924917 | HARMONIC SCALPEL 5MM LAPAROSONIC BLADE ACCESSORY | GEI | 1993-05-21 | 234 |
| K925699 | HARMONIC SCALPEL LAPAROSONIC CLAMP COAGULATOR ACC. | GCJ | 1993-05-17 | 186 |
| K924281 | HARMONIC SCALPEL LAPAROSONIC BLADE ACCESSORY | GCJ | 1993-04-23 | 241 |
| K911341 | HARMONIC SCALPEL ENDOSCOPIC BLADE COUPLER EXTENSIO | GEI | 1991-06-24 | 90 |
| K905315 | ULTRACISION HARMONIC SCALPEL | GEI | 1991-02-15 | 79 |
| K895252 | ULTRACISION ULTRASONIC SCALPEL | GEI | 1989-10-31 | 71 |
Recalls
openFDA lists no recalls under a recalling firm named Ultracision, 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 Ultracision, Inc. have?
Ultracision, Inc. has 9 FDA 510(k) clearances (first 1989, latest 1995), across 2 product codes in 1 review panel.
How long does FDA take to clear Ultracision, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Ultracision, Inc.'s cleared 510(k)s is 90 days.
What devices does Ultracision, Inc. make?
Its most frequent FDA product codes are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 6); GCJ (Laparoscope, General & Plastic Surgery, 3).
Has Ultracision, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Ultracision, Inc. Related entities may recall under other names.
Next steps
- See all 9 Ultracision, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Ultracision, 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.