Home / 510(k) Clearances / K944238

510(k) K944238

ENDOCYTE TM by D.L. Nelson and Assoc., Inc. — Product Code HCY

K944238 is an FDA 510(k) premarket notification submitted by D.L. Nelson and Assoc., Inc. for the device "ENDOCYTE TM". The FDA issued a decision of Substantially Equivalent on September 15, 1995. The device falls under product code HCY (Curette, Uterine), a Class I device regulated under 21 CFR 884.4530. D.L. Nelson and Assoc., Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1995
Date Received
August 31, 1994
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 D.L. Nelson and Assoc., Inc.

  • K945415 — 'LIL MAC ACCESSORY CLAMP(TM) (November 22, 1994)
  • K925035 — MIDKIFF GEOSTATIC CLAMP (February 18, 1993)
  • K904826 — TKO TELESCOPING LITHOTOMY STIRRUP (October 31, 1990)

Other clearances for product code HCY

  • K980096 — OAC (OPTICAL ASPIRATING CURETTE) (May 1, 1998)
  • 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