INSORB ABSORBALBE STAPLE— 510(k) K120373
Substantially EquivalentIncisive Surgical, Inc.
FDA 510(k) clearance K120373 for INSORB ABSORBALBE STAPLE, Substantially Equivalent on 2012-03-16. Applicant: Incisive Surgical, Inc.. Device class: 2.
Clearance details
- Applicant
- Incisive Surgical, Inc.
- Product code
- Code GDW
- Device class
- Class 2
- Regulation
- 21 CFR 878.4750
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Plymouth, MN, US
Recent devices under product code GDW
view allMore clearances from Incisive Surgical, Inc.
view allAdverse events under product code GDW
product code GDW- Death
- 450
- Injury
- 12,684
- Malfunction
- 68,730
- Other
- 6
- Total
- 81,870
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K120373
K-number listed on FDA's recall record- Z-0078-2019 — INSORB SUBCUTICULAR SKIN STAPLER, REF 2030
- 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.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K120373.
Data sourced from openFDA. This site is unofficial and independent of the FDA.