Gastroenterology-Urology · 510(k) · 2018
TransEnterix Senhance Surgical System
TransEnterix, Inc.. Cleared by FDA on 25 May 2018 under submission K180163, product code NAY (system, surgical, computer controlled instrument). What FDA's record says, in FDA's words.
Device record · K180163
- Device. TransEnterix Senhance Surgical SystemDEVICE
- Company. TransEnterix, Inc.COMPANY
- Decision. 25 May 2018, 510(k), substantially equivalent (traditional review); received 19 January 2018DECISION
- Panel. Gastroenterology-UrologyPANEL
- Product code. NAY, System, Surgical, Computer Controlled InstrumentCODE
- Regulation. 21 CFR 876.1500, Class IIREG
- Source. FDA database entry · decision document (12 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The Senhance Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization and retraction. The Senhance Surgical System is intended for use in laparoscopic gynecological surgery, colorectal surgery, cholecystectomy, and inguinal hernia repair. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the Instructions for Use.
The product code's definition, from FDA's classification record. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedendoscopy
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 143,880 reports filed against devices carrying product code NAY. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
30 September 2026 · Malfunction · EndoWrist · INTUITIVE SURGICAL, INC · report 2955842-2026-40378
It was reported that there was a broken cable with a da Vinci product. The customer reported event has no report of patient injury.
30 September 2026 · Malfunction · EndoWrist · INTUITIVE SURGICAL, INC · report 2955842-2026-40370
It was reported that there was a broken cable with a da Vinci product. The customer reported event has no report of patient injury.
30 September 2026 · Malfunction · EndoWrist · INTUITIVE SURGICAL, INC · report 2955842-2026-40363
It was reported that during a da Vinci-assisted surgical procedure, the Monopolar Curved Scissors had broken conductor wire (black). The procedure was completing as planned with no reported injury.ISI followed up with the initial reporter and obtained the following additional information: Based on the structure of Monopolar Curved Scissors, conductor wire cannot be confirmed visually. Thus, report of ¿conductor wire damage¿ can be considered as ¿cable¿ damage.
30 September 2026 · Malfunction · EndoWrist · INTUITIVE SURGICAL, INC · report 2955842-2026-40345
It was reported that there was a broken cable with a da Vinci product. The customer reported event has no report of patient injury.Review of the provided image is consistent with broken cable. Root cause of the failure mode cannot be confirmed without the returned device.
30 September 2026 · Malfunction · EndoWrist · INTUITIVE SURGICAL, INC · report 2955842-2026-40272
It was reported that there was a frayed cable with a da Vinci product. The customer reported event has no report of patient injury.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code NAY, in Gastroenterology-Urology, or cleared in 2018. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.