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510(k) K862476

LS3000 CANNULA UTERINE SUCTION by Engineering, Inc. — Product Code HHI

K862476 is an FDA 510(k) premarket notification submitted by Engineering, Inc. for the device "LS3000 CANNULA UTERINE SUCTION". The FDA issued a decision of Substantially Equivalent on July 18, 1986. The device falls under product code HHI (System, Abortion, Vacuum), a Class II device regulated under 21 CFR 884.5070. Engineering, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1986
Date Received
June 30, 1986
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 Engineering, Inc.

  • K881521 — MODIFIED SERVO SYRINGE (May 31, 1988)
  • K862749 — LS9000 SUCTION BIOPSY NEEDLE (September 15, 1986)
  • K854359 — LM2000A SURGICAL SUCTION MONITOR (March 3, 1986)
  • K854844 — LS1000 SURGICAL ASPIRATOR II (February 12, 1986)

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