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510(k) K902019

MODIFIED METAL SPECULUM & SPECIAL BULLET FORCEPS by Gynescope Corp. — Product Code HDF

K902019 is an FDA 510(k) premarket notification submitted by Gynescope Corp. for the device "MODIFIED METAL SPECULUM & SPECIAL BULLET FORCEPS". The FDA issued a decision of Substantially Equivalent on June 7, 1990. The device falls under product code HDF (Speculum, Vaginal, Metal), a Class I device regulated under 21 CFR 884.4520. Gynescope Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 1990
Date Received
May 3, 1990
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 Gynescope Corp.

  • K902657 — GYNESCOPE LAPAROSCOPIC FORCEPS (September 19, 1990)
  • K902658 — GYNESCOPE MONOPOLAR FORCEPS AND ELECTRODES (September 19, 1990)
  • K901530 — WALLACE INTRAUTERINE INSEMINATION CATHETER (July 23, 1990)
  • K902655 — GYNESCOPE LAPAROSCOPES (July 13, 1990)
  • K902656 — GYNESCOPE LAPAROSCOPIC TROCARS AND SLEEVES (June 29, 1990)
  • K902049 — CROAK OVARIAN BIOPSY FORCEP (June 7, 1990)
  • K900878 — OTT INSUFFLATION FILTER TUBING (May 7, 1990)
  • K895225 — GYNECOLOGICAL INSTRUMENTATION (March 5, 1990)

Other clearances for product code HDF

  • K926429 — VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT (February 28, 1994)
  • 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)
  • 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