Molli Surgical, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Molli Surgical, Inc.” (first 2021, latest 2024), across 1 product code in 1 review panel. Median 510(k) review time under this name: 148 days. Since 2017 the median was 148 days, against 123 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2021 | 1 | 46 |
| 2022 | 0 | — |
| 2023 | 2 | 129 |
| 2024 | 2 | 268 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Molli Surgical, Inc. took a median 148 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 123 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NEU | Marker, Radiographic, Implantable | 5 | 5 |
Review panels
Most recent Molli Surgical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K234149 | MOLLI 2 System | NEU | 2024-09-26 | 272 |
| K240042 | MOLLI 2 System | NEU | 2024-09-25 | 264 |
| K231579 | MOLLI 2 | NEU | 2023-10-26 | 148 |
| K223107 | MOLLI 2 | NEU | 2023-01-18 | 110 |
| K210600 | MOLLI | NEU | 2021-04-16 | 46 |
Recalls
openFDA lists no recalls under a recalling firm named Molli Surgical, Inc..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Molli Surgical, Inc. (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Molli Surgical, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Molli Surgical, Inc.” (first 2021, latest 2024), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Molli Surgical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Molli Surgical, Inc. is 148 days. Since 2017: 148 days, versus 123 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Molli Surgical, Inc.?
The most frequent FDA product codes under this applicant name are NEU (Marker, Radiographic, Implantable, 5).
Next steps
- See all 5 Molli Surgical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NEU, Molli Surgical, Inc.'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.