Incisive Surgical Inc
FDA Regulatory Profile
Incisive Surgical Inc appears in FDA public data with 2 recalls, 5 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0078-2019, Class II) was initiated on August 29, 2018. Its most recent 510(k) clearance was granted on March 16, 2012.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 5
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0078-2019 | Class II | INSORB SUBCUTICULAR SKIN STAPLER, REF 2030 | August 29, 2018 |
| Z-1545-2015 | Class II | Insorb Subcuticular Skin Stapler. INSORB staples are made from an absorbable copolymer which is a s | March 19, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K120373 | INSORB ABSORBALBE STAPLE | March 16, 2012 |
| K090159 | INSORB ABSORBABLE STAPLE, MODEL 1020, 1025, AND OTHER PRODUCT FAMILIES | February 6, 2009 |
| K061784 | INSORB ABSORBABLE STAPLE, MODEL 1020 | July 26, 2006 |
| K033602 | INSORB ABSORBABLE STAPLE, MODEL SP-B20 | December 16, 2003 |
| K024117 | INSORB ABSORBABLE STAPLES, MODEL SP-B20 | April 22, 2003 |