JUSTRIGHT 5MM STAPLER, JUSTRIGHT 5MM RELOAD— 510(k) K132472
Substantially EquivalentJustright Surgical, LLC
FDA 510(k) clearance K132472 for JUSTRIGHT 5MM STAPLER, JUSTRIGHT 5MM RELOAD, Substantially Equivalent on 2014-02-11. Applicant: Justright Surgical, LLC. Device class: 2.
Clearance details
- Applicant
- Justright Surgical, LLC
- 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
- Traditional
- Location
- Newbury, NH, US
Recent devices under product code GDW
view allMore clearances from Justright Surgical, LLC
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 K132472
K-number listed on FDA's recall record- Z-2690-2014 — Justright Surgical, JustRight 5mm Stapler, REF JR-ST25-2.0, Sterile, EO, Rx Only, JR-ST25-2.0 product is packaged in cases of 6. The JustRight 5mm Stapler is intended for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomosis.
- Z-2691-2014 — Justright Surgical, JustRight 5mm Reload, REFJR-REL25-2.0, Sterile, EO, Rx Only It is a replacement cartridge used when more than one firing is required during a surgery.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K132472.
Data sourced from openFDA. This site is unofficial and independent of the FDA.