Bioseal: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Bioseal” (first 1988, latest 1989), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 37 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| EFQ | Gauze/Sponge, Internal | 3 | 3 |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | 3 | 3 |
| CBH | Device, Fixation, Tracheal Tube | 1 | 1 |
| ECI | Band, Elastic, Orthodontic | 1 | 1 |
| LRO | General Surgery Tray | 1 | 1 |
| NAD | Dressing, Wound, Occlusive | 1 | 1 |
Review panels
- General and Plastic Surgery (8)
- Anesthesiology (1)
- Dental (1)
Most recent Bioseal 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K893814 | SURGICAL INSTRUMENT KIT, DISPOSABLE | LRO | 1989-08-10 | 79 |
| K882695 | RUBBER BAND, STERILE | ECI | 1988-10-13 | 108 |
| K882696 | DERMICEL, MONTGOMERY STRAP | NAD | 1988-08-26 | 60 |
| K882694 | FIXATION DEVICE, TRACH TUBE | CBH | 1988-08-15 | 49 |
| K882712 | STICK SPONGE | EFQ | 1988-08-03 | 37 |
| K882711 | GAUZE SPONGE 12PLY | EFQ | 1988-08-03 | 37 |
| K882710 | INTESTINAL SPONGES | EFQ | 1988-08-03 | 37 |
| K882709 | TONSIL SPONGE, X-RAY DETECTABLE, W/STRING | GDY | 1988-08-03 | 37 |
| K882708 | GAUZE SPONGE, X-RAY DETECTABLE | GDY | 1988-08-03 | 37 |
| K882707 | GAUZE PACKING, X-RAY DETECTABLE | GDY | 1988-08-03 | 37 |
Recalls
5 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2021-03-23.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Bioseal?
FDA lists 10 510(k) clearances under the applicant name “Bioseal” (first 1988, latest 1989), across 6 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Bioseal?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bioseal is 37 days.
Which FDA product codes appear under Bioseal?
The most frequent FDA product codes under this applicant name are EFQ (Gauze/Sponge, Internal, 3); GDY (Gauze/Sponge, Internal, X-Ray Detectable, 3); CBH (Device, Fixation, Tracheal Tube, 1).
Next steps
- See all 10 Bioseal clearances with predicates and recalls
- Run predicate analysis for product code EFQ, Bioseal's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.