TransEnterix Senhance Surgical System

K180163

TransEnterix, Inc. · cleared 2018-05-25 · product code NAY · Gastroenterology-Urology

Premarket evidence — what FDA accepted

Device typehardware
source quote (p.4)
“The Senhance Surgical System is a console-based, multi-arm surgical system, which enables a surgeon to remotely control surgical instrumentation during minimally invasive surgery in the lower abdomen and pelvis. The capital equipment is comprised of three main sub-systems as follows: Cockpit, Manipulator Arms, Node.”
AlgorithmFDA source did not state this
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Retrospective clinical

n=40 patients · 2 site(s)

endpoints: Complication Non-serious (Clavien Dindo I-II); Serious Complication (Clavien Dindo III); Estimated Blood Loss (mL); Intra-op Adverse Events / Complications; Transfusions (%); Mortality (%); Conversion to Laparoscopy; Conversion to Open; Reoperation rates; Readmission rates; Median Operative Time in min (range); Hospital Length of Stay (days)

Retrospective clinical

n=64 patients

endpoints: Intraoperative Complications; Transfusions; Postoperative Complications; Readmission Rates; Reoperation Rates; Mortality; Operative Time; All Complications

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

55
recalls in product code, 24mo
48042
MAUDE reports in code, 12mo
+163%
vs code's own 3-yr baseline
4
drift signals on this device
  • adverse_event_inflection

    MAUDE adverse-event reports for product code NAY: 48042 in the 12 months ending 2026-06, vs a 18259/12mo average over the prior 3 windows (+163%). Code-level count — reports are not attributed to this specific device.

    first seen 2026-07-08 · openFDA /device/event.json count=date_received product_code=NAY

  • recall_reason_pattern

    Software/algorithm-related recall in product code NAY (Intuitive Surgical, Inc., initiated 2025-12-30): "Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maint" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98205

  • recall_reason_pattern

    Software/algorithm-related recall in product code NAY (Intuitive Surgical, Inc., initiated 2025-11-17): "An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98200

  • recall_reason_pattern

    Software/algorithm-related recall in product code NAY (Intuitive Surgical, Inc., initiated 2025-11-07): "Due to a software implementation error that allowed instruments arms failing an important diagnostic test to remain in clinical use. This test was supposed to be used to detect Uni" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98050

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Gastroenterology-Urology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K180163