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510(k) K090902

SPIDER SINGLE PORT SURGICAL DEVICE, SUPPORT ARM ACCESSORY, MODEL 90001, 90002, 90003 by Transenterix, Inc. — Product Code GCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2009
Date Received
April 1, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laparoscope, General & Plastic Surgery
Device Class
Class II
Regulation Number
876.1500
Review Panel
SU
Submission Type

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Transenterix, Inc.

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  • K192877 — Senhance Surgical System (November 22, 2019)
  • K191482 — Senhance Surgical System (July 11, 2019)
  • K182421 — Senhance Ultrasonic System (January 11, 2019)
  • K183098 — Senhance Surgical System (December 6, 2018)
  • K181517 — Senhance Surgical System (October 9, 2018)
  • K180163 — TransEnterix Senhance Surgical System (May 25, 2018)
  • K171120 — Senhance Surgical Robotic System (October 13, 2017)
  • K122299 — SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR GRASPER WAVY RATCHETED, SPIDER S (October 25, 2012)

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