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510(k) K193315

Xenocor Articulating Xenoscope Laparoscope by Xenocor, Inc. — Product Code GCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2020
Date Received
November 29, 2019
Clearance Type
Special
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 Xenocor, Inc.

  • K260177 — Saberscope™ Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1) (February 12, 2026)
  • K220872 — Saberscope5 Laparoscope (April 20, 2022)
  • K171344 — Xenocor Xenoscope Laparoscopic System (June 1, 2017)
  • K161838 — Xenocor Xenoscope Laparoscopic System (September 26, 2016)

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  • K260177 — Saberscope™ Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1) (February 12, 2026)
  • K251923 — Medical Shaver System (Morcellator) (YSB-IIIA) (January 29, 2026)
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  • K254014 — Connected OR Hub with Device and Voice Control; SDC4K Information Management Sys (January 13, 2026)
  • K250927 — KARL STORZ Cholangiography Set (November 22, 2025)
  • K242606 — Nuvis® Wireless HD Camera System (Nuvis-2K) (November 20, 2025)
  • K252442 — Kii Structural Balloon Access System (October 31, 2025)