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510(k) K992926

GINRAM ENDOCIC SINGLE OVAL PORT (MODEL NO. 720195) by Ri Mos. S.R.L. — Product Code HHK

K992926 is an FDA 510(k) premarket notification submitted by Ri Mos. S.R.L. for the device "GINRAM ENDOCIC SINGLE OVAL PORT (MODEL NO. 720195)". The FDA issued a decision of Substantially Equivalent on October 26, 1999. The device falls under product code HHK (Curette, Suction, Endometrial (And Accessories)), a Class II device regulated under 21 CFR 884.1175. Ri Mos. S.R.L. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 1999
Date Received
August 31, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Curette, Suction, Endometrial (And Accessories)
Device Class
Class II
Regulation Number
884.1175
Review Panel
OB
Submission Type

Other clearances by Ri Mos. S.R.L.

  • K991895 — RAMPIPELLA, SINGE PORT (720196) & WEDGE-SHAPED PORT (720217) (August 12, 1999)
  • K991827 — GINRAM SPECUVAG, GINRAM SPECUVAG AS, GINRAM CUSCOVAG, MODELS 720101, 720102, 720 (July 19, 1999)
  • K983897 — CERVICAL ANESTHESIA NEEDLE, CONTRACERVICAL ANESTHESIA NEEDLE, MODEL #'S 720209 3 (February 1, 1999)

Other clearances for product code HHK

  • K251882 — Uterine Aspiration Set (October 16, 2025)
  • K240434 — RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6) (September 25, 2024)
  • K201952 — CrossGlide ETS Plus (August 5, 2020)
  • K192534 — CrossBay Endometrial Tissue Sampler (ETS) (March 25, 2020)
  • K102847 — DISPOSABLE ENDOMETRIAL SUCTION CURETTE (April 14, 2011)
  • K092982 — THE PANPAC SUCTION CURETTE (July 26, 2010)
  • K051294 — FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1 (December 21, 2005)
  • K040189 — ENDOMETRIAL SAMPLING SYRINGE (October 4, 2004)
  • K021876 — MAS WITH OR WITHOUT SYRINGE (April 8, 2003)
  • K020628 — CURELLE, PREFERRED CURELLE, CUTEQ 2.5 (May 24, 2002)

FDA data resources