ENDOPATH BLADELESS TROCAR, ENDOPATH BLUNT TIP TROCAR, ENDOPATH DILATING TIP TROCAR— 510(k) K032676
Substantially EquivalentEthicon Endo-Surgery, Inc.
FDA 510(k) clearance K032676 for ENDOPATH BLADELESS TROCAR, ENDOPATH BLUNT TIP TROCAR, ENDOPATH DILATING TIP TROCAR, Substantially Equivalent on 2003-10-30. Applicant: Ethicon Endo-Surgery, Inc.. Device class: 2.
Clearance details
- Applicant
- Ethicon Endo-Surgery, Inc.
- Product code
- Code GCJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cincinnati, OH, US
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More clearances from Ethicon Endo-Surgery, Inc.
view all- K141952 — ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCED
- 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
Adverse events under product code GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
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 K032676
K-number listed on FDA's recall record- Z-1885-2018 — 5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2B5LT
- Z-1886-2018 — 5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2B5ST
- Z-1887-2018 — 5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 150mm shaft length, 2B5XT
- Z-1888-2018 — 5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2CB5LT
- Z-1889-2018 — 5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2CB5ST
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K032676.
Data sourced from openFDA. This site is unofficial and independent of the FDA.