Incisive Surgical, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Incisive Surgical, Inc.” (first 2003, latest 2012), across 1 product code in 1 review panel. Median 510(k) review time under this name: 32 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 | 1 | 39 |
| 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 |
|---|---|---|---|
| GDW | Staple, Implantable | 5 | 5 |
Review panels
Most recent Incisive Surgical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K120373 | INSORB ABSORBALBE STAPLE | GDW | 2012-03-16 | 39 |
| K090159 | INSORB ABSORBABLE STAPLE, MODEL 1020, 1025, AND OTHER PRODUCT FAMILIES | GDW | 2009-02-06 | 15 |
| K061784 | INSORB ABSORBABLE STAPLE, MODEL 1020 | GDW | 2006-07-26 | 30 |
| K033602 | INSORB ABSORBABLE STAPLE, MODEL SP-B20 | GDW | 2003-12-16 | 32 |
| K024117 | INSORB ABSORBABLE STAPLES, MODEL SP-B20 | GDW | 2003-04-22 | 130 |
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2018-08-29.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Incisive, LLC (3 510(k)s)
- Incisive Technologies, Inc. (3 510(k)s)
- Incisive, Inc. (Formerly Named Incisive, LLC) (1 510(k)s)
- Incisive Technologies Pty, Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Incisive Surgical, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Incisive Surgical, Inc.” (first 2003, latest 2012), 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 Incisive Surgical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Incisive Surgical, Inc. is 32 days.
Which FDA product codes appear under Incisive Surgical, Inc.?
The most frequent FDA product codes under this applicant name are GDW (Staple, Implantable, 5).
Next steps
- See all 5 Incisive Surgical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GDW, Incisive 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.