Ultracell Medical Technologies, Inc.: FDA clearances and approvals
Ultracell Medical Technologies, Inc. has 24 FDA 510(k) clearances (first 1992, latest 2001), across 9 product codes in 6 review panels. Median 510(k) review time: 104 days. openFDA lists 13 product recalls by a recalling firm named Ultracell Medical Technologies, Inc.
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 |
|---|---|---|---|
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | 7 | 7 |
| EMX | Balloon, Epistaxis | 5 | 5 |
| HOZ | Sponge, Ophthalmic | 4 | 4 |
| HBA | Neurosurgical Paddie | 3 | 3 |
| FEB | Accessories, Cleaning, For Endoscope | 1 | 1 |
| GBX | Catheter, Irrigation | 1 | 1 |
| HEP | Monitor, Blood-Flow, Ultrasonic | 1 | 1 |
| KCN | Ear Wick | 1 | 1 |
| LYA | Splint, Intranasal Septal | 1 | 1 |
Review panels
- General and Plastic Surgery (8)
- Ear, Nose and Throat (7)
- Ophthalmic (4)
- Neurology (3)
- General Hospital (1)
- Obstetrics and Gynecology (1)
Most recent Ultracell Medical Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K012196 | ULTRACELL ABSORBENT STICK | HOZ | 2001-08-24 | 42 |
| K972634 | ULTRACELL SUCTION SPONGE | GDY | 1997-12-17 | 156 |
| K972633 | ULTRACELL SUCTION SPONGE | HOZ | 1997-12-17 | 156 |
| K973083 | ULTRACELL NEURO SPONGES | HBA | 1997-12-09 | 113 |
| K973558 | VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS) | FEB | 1997-11-24 | 66 |
| K973085 | ULTRACELL PACKING WITH SLEEVE | EMX | 1997-11-18 | 92 |
| K972635 | ULTRACELL SUCTION SPONGE | GBX | 1997-10-01 | 79 |
| K970328 | ULTRACELL NEURO SPONGES | HBA | 1997-04-21 | 84 |
| K950647 | ULTRACELL NEURO SPONGES | HBA | 1995-08-15 | 183 |
| K950373 | ULTRACELL ORTHOPEDIC SPONGES | GDY | 1995-04-17 | 76 |
14 earlier clearances. See the full list in Caduvo.
Recalls
13 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2003-01-08.
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 Ultracell Medical Technologies, Inc. have?
Ultracell Medical Technologies, Inc. has 24 FDA 510(k) clearances (first 1992, latest 2001), across 9 product codes in 6 review panels.
How long does FDA take to clear Ultracell Medical Technologies, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Ultracell Medical Technologies, Inc.'s cleared 510(k)s is 104 days.
What devices does Ultracell Medical Technologies, Inc. make?
Its most frequent FDA product codes are GDY (Gauze/Sponge, Internal, X-Ray Detectable, 7); EMX (Balloon, Epistaxis, 5); HOZ (Sponge, Ophthalmic, 4).
Has Ultracell Medical Technologies, Inc. had device recalls?
openFDA lists 13 product recalls in 1 recall event by a recalling firm whose name matches Ultracell Medical Technologies, Inc; the most recent began 2003-01-08. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 24 Ultracell Medical Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GDY, Ultracell Medical Technologies, 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.