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510(k) K881794

IVORY FINDER SET by Ivory Instruments Co. — Product Code HCY

K881794 is an FDA 510(k) premarket notification submitted by Ivory Instruments Co. for the device "IVORY FINDER SET". The FDA issued a decision of Substantially Equivalent on July 8, 1988. The device falls under product code HCY (Curette, Uterine), a Class I device regulated under 21 CFR 884.4530.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1988
Date Received
April 26, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Curette, Uterine
Device Class
Class I
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances for product code HCY

  • K980096 — OAC (OPTICAL ASPIRATING CURETTE) (May 1, 1998)
  • K944238 — ENDOCYTE TM (September 15, 1995)
  • K935822 — PHASE I CURETTE (April 28, 1994)
  • K901442 — BAXTER D & C TRAY (July 26, 1990)
  • K890384 — UTERINE CURETTE (February 13, 1989)
  • K862297 — THE D & C PAD-SAC (July 7, 1986)
  • K850068 — LUNE AU CURETTES (April 8, 1985)
  • K841004 — SURGICAL CURETTE, VARIOUS (May 11, 1984)
  • K802313 — UTERINE CURETTE (January 12, 1981)
  • K790032 — DISPOSABLE VACUUM CURETTE (February 1, 1979)

FDA data resources