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510(k) K230359

KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER- by Karl Storz Endoscopy America, Inc. — Product Code GCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2023
Date Received
February 10, 2023
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 Karl Storz Endoscopy America, Inc.

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  • K221893 — KARL STORZ Bipolar Resectoscopes with HF Cable (March 17, 2023)
  • K221004 — HOPKINS Telescopes (December 20, 2022)
  • K222504 — H1 (November 10, 2022)
  • K213194 — HD Mediastinoscope (June 23, 2022)
  • K221174 — Telepack + (May 13, 2022)
  • K212458 — Flexible Video-Uretero-Renoscope SSU System (January 20, 2022)
  • K212656 — Flexible Intubation Video Endoscope – Sterile (FIVE-S) (December 29, 2021)
  • K212695 — KARL STORZ ICG Imaging System (November 15, 2021)

Other clearances for product code GCJ

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  • 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)
  • K242606 — Nuvis® Wireless HD Camera System (Nuvis-2K) (November 20, 2025)
  • K252442 — Kii Structural Balloon Access System (October 31, 2025)