ENDOPATH ETS 35MM ENDOSCOPIC LINEAR CUTTER AND RELOADS, AND ETS-FLEX 35MM ENDOSCOPIC ARTICULATING LINEAR CUTTER AND RELO— 510(k) K111111
Substantially EquivalentEthicon Endo-Surgery, LLC
FDA 510(k) clearance K111111 for ENDOPATH ETS 35MM ENDOSCOPIC LINEAR CUTTER AND RELOADS, AND ETS-FLEX 35MM ENDOSCOPIC ARTICULATING LINEAR CUTTER AND RELO, Substantially Equivalent on 2011-06-08. Applicant: Ethicon Endo-Surgery, LLC. Device class: 2.
Clearance details
- Applicant
- Ethicon Endo-Surgery, 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
- Cincinnati, OH, US
Recent devices under product code GDW
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view all- K254196 — HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)
- K252906 — ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)
- K243276 — ECHELON LINEAR Stapler 30mm Stapler (GTX30) +8 more
- K241630 — ECHELON 4000 60mm Compact Stapler (EC3D60C) +6 more
- K241629 — ECHELON 3000 45mm Compact Stapler (ECH45C) +5 more
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 K111111
K-number listed on FDA's recall record- Z-2174-2017 — Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM
- Z-0295-2017 — Endoscopic Articulating Linear Cutter, ATB35. Standard 35 MM. The ENDOPATH ETS-Flex Endoscopic Articulating Linear Cutter has application in general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses
- Z-0296-2017 — Endoscopic Articulating Linear Cutter, 38ATW35. VASCULAR/THIN 35MM The ENDOPATH ETS-Flex Endoscopic Articulating Linear Cutter has application in general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111111.
Data sourced from openFDA. This site is unofficial and independent of the FDA.