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510(k) K890375

VAGINAL SPECULUM by Kinetic Medical Products — Product Code HDF

K890375 is an FDA 510(k) premarket notification submitted by Kinetic Medical Products for the device "VAGINAL SPECULUM". The FDA issued a decision of Substantially Equivalent on February 13, 1989. The device falls under product code HDF (Speculum, Vaginal, Metal), a Class I device regulated under 21 CFR 884.4520. Kinetic Medical Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 1989
Date Received
January 23, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Speculum, Vaginal, Metal
Device Class
Class I
Regulation Number
884.4520
Review Panel
OB
Submission Type

Other clearances by Kinetic Medical Products

  • K890385 — MIDWIFERY/OBSTETRICAL FORCEPS (March 1, 1989)
  • K890380 — CERVICAL BIOPSY FORCEPS (February 27, 1989)
  • K890387 — MALLEABLE PLACENTA CURETTE (February 27, 1989)
  • K890376 — VAGINAL SPECULUM (February 27, 1989)
  • K890382 — COMPRESSION FORCEPS (February 27, 1989)
  • K890383 — HYSTERECTOMY FORCEPS (February 16, 1989)
  • K890216 — MICROSURGICAL KERATOME (February 16, 1989)
  • K890389 — UMBILICAL SCISSORS (February 13, 1989)
  • K890388 — CEPHALOTOMY SCISSORS (February 13, 1989)
  • K890378 — UTERINE DRESSING FORCEPS (February 13, 1989)

Other clearances for product code HDF

  • K926429 — VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT (February 28, 1994)
  • K902019 — MODIFIED METAL SPECULUM & SPECIAL BULLET FORCEPS (June 7, 1990)
  • K891041 — MIYA SPECULUM (March 22, 1989)
  • K891044 — LASER SPECULA (March 17, 1989)
  • K862478 — HAYES VAGINAL SHIELD (November 24, 1986)
  • K853640 — WELLINGTON HOSPITAL PATTERN SELF RETAINING VAGINAL (October 29, 1985)
  • K851799 — 61-100 TO 61-124 VARIOUS VAGINAL SPECVIA(CUSCO,GRA (May 22, 1985)
  • K843388 — WELLINGTON HOSPITAL PATTERN SELF-RETAIN (October 1, 1984)
  • K821297 — GRAVES SPECULA (May 24, 1982)
  • K821291 — PEDERSON VAGINAL SPECULA (May 24, 1982)

FDA data resources