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510(k) K980096

OAC (OPTICAL ASPIRATING CURETTE) by Imagyn Medical Technologies, Inc. — Product Code HCY

K980096 is an FDA 510(k) premarket notification submitted by Imagyn Medical Technologies, Inc. for the device "OAC (OPTICAL ASPIRATING CURETTE)". The FDA issued a decision of Substantially Equivalent on May 1, 1998. The device falls under product code HCY (Curette, Uterine), a Class I device regulated under 21 CFR 884.4530. Imagyn Medical Technologies, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 1998
Date Received
January 9, 1998
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 Imagyn Medical Technologies, Inc.

  • K032491 — ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR (September 4, 2003)
  • K012706 — IM2001 PULSE OXIMETER (March 7, 2003)
  • K010166 — IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM (December 3, 2001)
  • K991526 — ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501 (June 17, 1999)
  • K980291 — IMPOWER EXTERNAL VACUUM SYSTEM (March 11, 1998)
  • K974173 — ERECAID SYSTEM/STAY EREC SYSTEM (February 25, 1998)

Other clearances for product code HCY

  • 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)
  • K790032 — DISPOSABLE VACUUM CURETTE (February 1, 1979)

FDA data resources