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510(k) K993749

GYRUS HYSTEROSCOPIC RESECTOSCOPE by Gyrus Medical , Ltd. — Product Code HIH

K993749 is an FDA 510(k) premarket notification submitted by Gyrus Medical , Ltd. for the device "GYRUS HYSTEROSCOPIC RESECTOSCOPE". The FDA issued a decision of Substantially Equivalent on December 3, 1999. The device falls under product code HIH (Hysteroscope (And Accessories)), a Class II device regulated under 21 CFR 884.1690. Gyrus Medical , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 1999
Date Received
November 5, 1999
Clearance Type
Special
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 Gyrus Medical , Ltd.

  • K050550 — GYRUS GENERAL PURPOSE ELECTROSURGICAL GENERATOR (November 9, 2005)
  • K050460 — GYRUS PLASMACISION AND PLASMABLEND ELECTRODES (October 25, 2005)
  • K041999 — GYRUS PLASMA SKIN RESURFACING SYSTEM (March 2, 2005)
  • K041633 — GYRUS PLASMACISION LAPAROSCOPIC SPATULA (October 22, 2004)
  • K041285 — GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION (September 10, 2004)
  • K024286 — GYRUS OPEN FORCEPS (November 17, 2003)
  • K031085 — GYRUS PLASMAKINETIC SUPERPULSE SYSTEM (GENERATOR, ACCESSORIES) (July 21, 2003)
  • K031079 — EVEREST BIPOLAR NEEDLE ELECTRODE & GYRUS BIPOLAR NEEDLE ELECTRODE (May 21, 2003)
  • K031082 — EVEREST BIPOLAR L HOOK & PK BIPOLAR L HOOK (May 21, 2003)
  • K031081 — EVEREST LP BIPOLAR SCISSORS AND GYRUS LP BIPOLAR SCISSORS (May 21, 2003)

Other clearances for product code HIH

  • K253020 — Strauss Surgical Resection Instruments (June 4, 2026)
  • K254050 — Manual Tissue Removal Device (May 15, 2026)
  • K254251 — InnovexView (GC146-17, GC150-20, GC155-23) (February 26, 2026)
  • K252793 — ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysterosc (December 18, 2025)
  • K252012 — SPY Cystoscope/Hysteroscope (July 18, 2025)
  • K243382 — RZ Resectoscope System (June 3, 2025)
  • 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)

FDA data resources