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510(k) K021876

MAS WITH OR WITHOUT SYRINGE by Marina Medical Instruments, Inc. — Product Code HHK

K021876 is an FDA 510(k) premarket notification submitted by Marina Medical Instruments, Inc. for the device "MAS WITH OR WITHOUT SYRINGE". The FDA issued a decision of Substantially Equivalent on April 8, 2003. The device falls under product code HHK (Curette, Suction, Endometrial (And Accessories)), a Class II device regulated under 21 CFR 884.1175. Marina Medical Instruments, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2003
Date Received
June 7, 2002
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 Marina Medical Instruments, Inc.

  • K042534 — MARINA MEDICAL FINGER PROTECTORS (May 10, 2005)
  • K031463 — MARINA MEDICAL SILICONE PESSARY (November 18, 2003)
  • K023725 — HEMORRHAGE OCCLUDER PIN (HOP), MODEL 337-247 (February 3, 2003)
  • K010296 — UTERINE MANIPULATOR INJECTOR CANNULA, MODEL R57-450 (April 11, 2001)

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)
  • K020628 — CURELLE, PREFERRED CURELLE, CUTEQ 2.5 (May 24, 2002)
  • K001555 — SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26 (August 2, 2000)

FDA data resources