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510(k) K813282

SYNEVAC VACUUM CURETTAGE SYSTEMS by Synemed, Inc. — Product Code HHI

K813282 is an FDA 510(k) premarket notification submitted by Synemed, Inc. for the device "SYNEVAC VACUUM CURETTAGE SYSTEMS". The FDA issued a decision of Substantially Equivalent on December 14, 1981. The device falls under product code HHI (System, Abortion, Vacuum), a Class II device regulated under 21 CFR 884.5070. Synemed, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 1981
Date Received
November 17, 1981
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 Synemed, Inc.

  • K954037 — FIELD TREND (November 17, 1995)
  • K852936 — THE FIELDMASTER MODEL 275 (October 15, 1985)
  • K833274 — DERMATOLOGY HANDPIECE-OPHTH LASER (December 3, 1983)
  • K831085 — SYNEVAC VACUUM SOURCE UNIT (June 8, 1983)
  • K828585 — OPTHALAS PHOTOCOAGULATOR (January 3, 1983)
  • K822853 — MODEL 200 SQUID (October 18, 1982)
  • K811270 — SCOPE MASTER (September 8, 1981)

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