SPIDER SURGICAL INSTRUMENTS, MODELS 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015— 510(k) K091697
Substantially EquivalentTransenterix, Inc.
FDA 510(k) clearance K091697 for SPIDER SURGICAL INSTRUMENTS, MODELS 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015, Substantially Equivalent on 2009-09-28. Applicant: Transenterix, Inc.. Device class: 2.
Clearance details
- Applicant
- Transenterix, 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
- Durham, NC, US
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- K261139 — VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)
- K253541 — EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)
More clearances from Transenterix, Inc.
view allAdverse 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 K091697
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K091697.
Data sourced from openFDA. This site is unofficial and independent of the FDA.