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510(k) K862478

HAYES VAGINAL SHIELD by Franklin Medical USA, Inc. — Product Code HDF

K862478 is an FDA 510(k) premarket notification submitted by Franklin Medical USA, Inc. for the device "HAYES VAGINAL SHIELD". The FDA issued a decision of Substantially Equivalent on November 24, 1986. The device falls under product code HDF (Speculum, Vaginal, Metal), a Class I device regulated under 21 CFR 884.4520. Franklin Medical USA, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1986
Date Received
June 30, 1986
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 Franklin Medical USA, Inc.

  • K931488 — KSF SPINAL FIXATOR (January 21, 1994)
  • K884589 — FRANTZ MEDICAL SHARPS COLLECTOR (December 9, 1988)
  • K852200 — SIMPLASTIC SUPRA PUBIC CATHETER (August 7, 1985)

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)
  • 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