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510(k) K841631

MODEL 3014 SUCTION UNIT by Forma Scientific, Inc. — Product Code HHI

K841631 is an FDA 510(k) premarket notification submitted by Forma Scientific, Inc. for the device "MODEL 3014 SUCTION UNIT". The FDA issued a decision of Substantially Equivalent on July 3, 1984. The device falls under product code HHI (System, Abortion, Vacuum), a Class II device regulated under 21 CFR 884.5070. Forma Scientific, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 1984
Date Received
April 20, 1984
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 Forma Scientific, Inc.

  • K823356 — READY-BOX BODY-TEMP MEDIA WARMER MALLIN- (December 3, 1982)
  • K821401 — MALLINCKRODT DIAG. MEDIA WARMER (June 17, 1982)
  • K812826 — FORMA CH/P GAS PROCESSOR (October 23, 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