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510(k) K990334

KSEA ENDOSCOPE HOLDER by KARL STORZ Endoscopy-America, Inc. — Product Code OCV

K990334 is an FDA 510(k) premarket notification submitted by KARL STORZ Endoscopy-America, Inc. for the device "KSEA ENDOSCOPE HOLDER". The FDA issued a decision of Substantially Equivalent on March 22, 1999. The device falls under product code OCV (Endoscope Holder), a Class II device regulated under 21 CFR 876.1500. KARL STORZ Endoscopy-America, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1999
Date Received
February 3, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope Holder
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To hold endoscope in a desired position during procedures.

Other clearances by KARL STORZ Endoscopy-America, Inc.

  • K252624 — KARL STORZ Laryngoscopes and Accessories (May 15, 2026)
  • K223923 — HOPKINS Telescopes (March 30, 2023)
  • K202957 — Flexible Video Cysto-Urethroscope (C-view) (October 29, 2020)
  • K200318 — UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver (October 22, 2020)
  • K201135 — Image1 S CCU, Image1 S 4U Camera Head (September 1, 2020)
  • K200740 — HD Video Rhino Laryngoscope (August 11, 2020)
  • K191357 — Flexible HD Cysto-Urethroscope System (September 18, 2019)
  • K182723 — Flexible HD Cysto-Urethroscope System (April 23, 2019)
  • K182186 — CMOS Video-Rhino-Laryngoscope System (March 22, 2019)
  • K183264 — Flex-THOR scope (January 18, 2019)

Other clearances for product code OCV

  • K240506 — KARL STORZ Holders (October 22, 2024)
  • K232405 — ENDOFIX EXO (April 25, 2024)
  • K190576 — WalterLorenz Surgical Assist Arm Scope Holder (June 5, 2019)
  • K102179 — ENVIEW (TM) (December 2, 2010)
  • K093616 — V. MUELLER CAMERA CONTROLLER WITH STORAGE CART (December 23, 2009)
  • K992006 — NEUROVIEW INSTRUMENT HOLDER, MODEL 300-33 (August 17, 1999)
  • K971584 — CLARUS MODEL 2127-900 SERIES ENDOSCOPE ADATER (2127-900 SERIES) (May 23, 1997)
  • K960068 — SH-1 SURGICAL HOLDER FOR TELESCOPE (May 5, 1997)
  • K810787 — UROLOGIC TUBE HOLDER (March 31, 1981)

FDA data resources