Home / 510(k) Clearances / K853640

510(k) K853640

WELLINGTON HOSPITAL PATTERN SELF RETAINING VAGINAL by Downs Surgical , Ltd. — Product Code HDF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 1985
Date Received
August 20, 1985
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 Downs Surgical , Ltd.

  • K903747 — ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-U (October 31, 1990)
  • K903749 — ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-596-00-U (October 31, 1990)
  • K903748 — ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-V (October 31, 1990)
  • K903750 — ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-598-OO-E (October 31, 1990)
  • K900610 — SHEPPERD CANNULA STILLETTE & OBDURATOR SET (October 22, 1990)
  • K900609 — SHEPPERD STRAIGHT AND CURVED NEEDLES (October 22, 1990)
  • K900611 — SHEPPERD DILATATION TUBE SET (GS-501-20-H) (October 22, 1990)
  • K900613 — SHEPPERD SHELTER TUBE COMPLETE & DRILL (October 22, 1990)
  • K900608 — SHEPPERD LUMBAR DISCECTOMY SYSTEM (October 22, 1990)
  • K900615 — SHEPPERD NERVE ROOT RETRACTOR W/SUCTION & FIBRE (October 22, 1990)

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)
  • K890375 — VAGINAL SPECULUM (February 13, 1989)
  • K862478 — HAYES VAGINAL SHIELD (November 24, 1986)
  • 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)