Home / 510(k) Clearances / K926429

510(k) K926429

VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT by Thomasville Medical Assoc. — Product Code HDF

K926429 is an FDA 510(k) premarket notification submitted by Thomasville Medical Assoc. for the device "VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT". The FDA issued a decision of Substantially Equivalent on February 28, 1994. The device falls under product code HDF (Speculum, Vaginal, Metal), a Class I device regulated under 21 CFR 884.4520. Thomasville Medical Assoc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1994
Date Received
December 23, 1992
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 Thomasville Medical Assoc.

  • K926471 — MOGAN CIRCUMCISION CLAMP (February 25, 1994)
  • K926527 — ROTO FIT BIOPSY FORCEPS (February 25, 1994)
  • K926531 — HYSTERECTOMY FORCEPS (February 25, 1994)
  • K926532 — ENDO CERVICAL CURETTE (February 25, 1994)
  • K926535 — GOMCO CIRCUMCISION CLAMP (February 25, 1994)
  • K926540 — SOPHER AND BIERER OVUM FORCEPS (February 25, 1994)
  • K926533 — Z-CLAMP FORCEPS (February 25, 1994)
  • K926536 — DISPOSABLE PLASTIC VAGINAL SPECULA (February 25, 1994)
  • K926484 — CORSON MYOMA GRASPING FORCEPS (February 25, 1994)
  • K930030 — SUCTION TUBES: HOUSE, BARON (February 25, 1994)

Other clearances for product code HDF

  • 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)
  • 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