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510(k) K850312

GYNASPYR VACUUM CURETTAGE UNIT by Roseburg SA — Product Code HHI

K850312 is an FDA 510(k) premarket notification submitted by Roseburg SA for the device "GYNASPYR VACUUM CURETTAGE UNIT". The FDA issued a decision of Substantially Equivalent on February 28, 1985. The device falls under product code HHI (System, Abortion, Vacuum), a Class II device regulated under 21 CFR 884.5070. Roseburg SA has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1985
Date Received
January 25, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Abortion, Vacuum
Device Class
Class II
Regulation Number
884.5070
Review Panel
OB
Submission Type

Other clearances by Roseburg SA

  • K931155 — STAPLE, FIXATION BONE; SCREW FIXATION BONE (September 1, 1994)
  • K890081 — CALIUS-ISABEL CANOVAS SUNGLASSES (March 9, 1989)
  • K885275 — ASSENAT-BLESCHET SUNGLASSES (January 24, 1989)
  • K882392 — BURNET LABORATOIRE PHARMACEUTIQUE SURGICAL GLOVES (August 26, 1988)
  • K872715 — UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY (December 7, 1987)
  • K874317 — POIRIER KID-ROLLER MANUAL WHEELCHAIR (November 17, 1987)
  • K872714 — S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY (July 21, 1987)
  • K871688 — SPECTACLE FRAME - DANIELLE (May 29, 1987)
  • K871689 — SPECTACLE FRAME - LORRAINE (May 29, 1987)
  • K870654 — EFER ARTHROSCOPE (May 14, 1987)

Other clearances for product code HHI

  • K171440 — Berkeley VC-10 Vacuum Curettage System (September 29, 2017)
  • K030935 — BERKELEY V-10 VACUUM CURETTAGE SYSTEM (June 23, 2003)
  • K983181 — CYTOPREP (November 16, 1998)
  • K931205 — MEDI VAC SPECIMEN COLLECTOR AND TRANSPORTER (March 15, 1994)
  • K904160 — CYTOSMEAR BRUSH (November 2, 1990)
  • K900641 — CANNULA, SUCTION UTERINE (March 30, 1990)
  • K900642 — SWIVEL ADAPTER (March 19, 1990)
  • K880734 — SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS (April 25, 1988)
  • K873552 — CANNULA AND GENERAL PURPOSE ASPIRATOR (November 25, 1987)
  • K870574 — COSMEDTECH GENERAL ASPIRATOR (March 5, 1987)

FDA data resources