Incisive Surgical, Inc.
Minnetonka, MN, US
Incisive Surgical, Inc. appears in FDA device records in Minnetonka, MN. FDA records list 5 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Incisive Surgical, Inc. between 2003 and 2012. The busiest year on record is 2003, with 2. The most recent is 2012, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 2 |
| 2006 | 1 |
| 2009 | 1 |
| 2012 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K120373 | INSORB ABSORBALBE STAPLE | GDW | Substantially Equivalent | |
| K090159 | INSORB ABSORBABLE STAPLE, MODEL 1020, 1025, AND OTHER PRODUCT FAMILIES | GDW | Substantially Equivalent | |
| K061784 | INSORB ABSORBABLE STAPLE, MODEL 1020 | GDW | Substantially Equivalent | |
| K033602 | INSORB ABSORBABLE STAPLE, MODEL SP-B20 | GDW | Substantially Equivalent | |
| K024117 | INSORB ABSORBABLE STAPLES, MODEL SP-B20 | GDW | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0078-2019 | INSORB SUBCUTICULAR SKIN STAPLER, REF 2030 | Possible compromise of the sterile barrier integrity | Class II | Terminated | |
| Z-1545-2015 | Insorb Subcuticular Skin Stapler. INSORB staples are made from an absorbable copolymer which is a synthetic polyester derived from lactic and glycolic acids. It is chemically similar to other surgical glycolide/lactide-based copolymers. Polyglycolic/polylactic acid copolymers degrade in vivo by hydrolysis to glycolic acid and lactic acid which are then absorbed and metabolized by the body. | A previous Turkish distributor over-labeled a portion of the lot with an expiration date of 2016-05. The expiration date at the time of manufacturing was 2014-05. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain