Home / 510(k) Clearances / K790032

510(k) K790032

DISPOSABLE VACUUM CURETTE by British Marketing Ent., Ltd. — Product Code HCY

K790032 is an FDA 510(k) premarket notification submitted by British Marketing Ent., Ltd. for the device "DISPOSABLE VACUUM CURETTE". The FDA issued a decision of Substantially Equivalent on February 1, 1979. The device falls under product code HCY (Curette, Uterine), a Class I device regulated under 21 CFR 884.4530. British Marketing Ent., Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 1979
Date Received
January 3, 1979
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 by British Marketing Ent., Ltd.

  • K782067 — DILATOR, MIZUTANI LAMINARIA TENT (January 3, 1979)

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)
  • K881794 — IVORY FINDER SET (July 8, 1988)
  • 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)

FDA data resources