SPIDER SURGICAL INSTRUMENTS, MODELS 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015— 510(k) K091697

Substantially Equivalent

Transenterix, 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..

Clearance details

Applicant: Transenterix, Inc.
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 2009-06-10
Decision date: 2009-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

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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, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.