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510(k) K193007

LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module by Lina Medical Aps — Product Code HIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2020
Date Received
October 28, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hysteroscope (And Accessories)
Device Class
Class II
Regulation Number
884.1690
Review Panel
OB
Submission Type

Other clearances by Lina Medical Aps

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  • K221085 — LiNA OperaScope Needle (September 2, 2022)
  • K182224 — SafeAir Smoke Evacuator compact (February 7, 2019)
  • K182354 — SafeAir Telescopic Smoke Pencil (December 14, 2018)
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  • K143145 — SafeAir Smoke Pencil (December 4, 2014)
  • K142757 — LiNA PowerBlade Plus HC (October 23, 2014)
  • K142538 — LiNA SafeAir Smoke Pencil (October 6, 2014)
  • K132135 — LINA GOLD LOOP HC (January 31, 2014)

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  • K240978 — SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, H (August 16, 2024)
  • K241987 — Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101) (August 2, 2024)
  • K240401 — ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS- (July 26, 2024)
  • K231260 — HTx Disposable Hysteroscope System (March 5, 2024)
  • K233635 — SPY Cystoscope/Hysteroscope (February 12, 2024)
  • K232003 — Endoscopic Video Image Processor, Single-Use Video Hysteroscope (February 12, 2024)