Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Incisive Surgical, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
32 daysmedian FDA review time
130 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K120373 | INSORB ABSORBALBE STAPLE | Incisive Surgical, Inc. | 2012-03-16 | 39 | 1 |
| K090159 | INSORB ABSORBABLE STAPLE, MODEL 1020, 1025, AND OTHER PRODUC | Incisive Surgical, Inc. | 2009-02-06 | 15 | 1 |
| K061784 | INSORB ABSORBABLE STAPLE, MODEL 1020 | Incisive Surgical, Inc. | 2006-07-26 | 30 | 1 |
| K033602 | INSORB ABSORBABLE STAPLE, MODEL SP-B20 | Incisive Surgical, Inc. | 2003-12-16 | 32 | 1 |
| K024117 | INSORB ABSORBABLE STAPLES, MODEL SP-B20 | Incisive Surgical, Inc. | 2003-04-22 | 130 | 1 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda