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510(k) K242606

Nuvis® Wireless HD Camera System (Nuvis-2K) by Integrated Endoscopy, Inc. — Product Code GCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2025
Date Received
August 30, 2024
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 Integrated Endoscopy, Inc.

  • K191594 — Nuvis Battery Arthroscope (July 11, 2019)
  • K140903 — NUVIS ARTHROSCOPE (July 17, 2014)

Other clearances for product code GCJ

  • K252714 — C-Lant Port (February 27, 2026)
  • K253978 — Universal Seal (5-12 mm) (February 24, 2026)
  • K260185 — 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with (February 18, 2026)
  • 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)
  • K252957 — Pneumo Dissector Hook (January 23, 2026)
  • K254014 — Connected OR Hub with Device and Voice Control; SDC4K Information Management Sys (January 13, 2026)
  • K250927 — KARL STORZ Cholangiography Set (November 22, 2025)
  • K252442 — Kii Structural Balloon Access System (October 31, 2025)
  • K252697 — 3D Laparoscope (October 29, 2025)