ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCED— 510(k) K141952
Substantially EquivalentEthicon Endo-Surgery, Inc.
FDA 510(k) clearance K141952 for ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCED, Substantially Equivalent on 2014-11-24. Applicant: Ethicon Endo-Surgery, Inc.. Device class: 2.
Clearance details
- Applicant
- Ethicon Endo-Surgery, 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
- Traditional
- Location
- Cincinnati, OH, US
Recent devices under product code GDW
view allMore clearances from Ethicon Endo-Surgery, Inc.
view all- K111195 — VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS
- K110385 — ECHELON FLEX 45 / 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER
- K101520 — ENSEAL TISSUE SEALING DEVICES MODEL: NSEAL514H-535H, NSEAL514RH-535RH
- K102632 — ETHICON ENDO-SURGERY 5MM LAPAROSCOPIC MULTI-FEED STAPLER
- K093896 — ETHICON ENDO SURGERY SLOTTED ANOSCOPE
Adverse 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 K141952
K-number listed on FDA's recall record- Z-1746-2025 — Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35
- Z-1641-2015 — ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip, Product Usage: The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic and pediatric surgical procedures.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K141952.
Data sourced from openFDA. This site is unofficial and independent of the FDA.