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510(k) K926541

IUD HOOKS by Thomasville Medical Assoc. — Product Code HHF

K926541 is an FDA 510(k) premarket notification submitted by Thomasville Medical Assoc. for the device "IUD HOOKS". The FDA issued a decision of Substantially Equivalent on February 24, 1994. The device falls under product code HHF (Remover, Intrauterine Device, Contraceptive, Hook-Type), a Class I device regulated under 21 CFR 884.4530. Thomasville Medical Assoc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1994
Date Received
December 30, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Remover, Intrauterine Device, Contraceptive, Hook-Type
Device Class
Class I
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances by Thomasville Medical Assoc.

  • K926429 — VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT (February 28, 1994)
  • K926527 — ROTO FIT BIOPSY FORCEPS (February 25, 1994)
  • K926533 — Z-CLAMP 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)
  • K926531 — HYSTERECTOMY FORCEPS (February 25, 1994)
  • K926536 — DISPOSABLE PLASTIC VAGINAL SPECULA (February 25, 1994)
  • K926484 — CORSON MYOMA GRASPING FORCEPS (February 25, 1994)
  • K926471 — MOGAN CIRCUMCISION CLAMP (February 25, 1994)

Other clearances for product code HHF

  • K891030 — IUD HOOKS - SIMPLE, UNIVERSAL AND SKLAR (March 17, 1989)
  • K842295 — INTRAUTERINE DEVICE REMOVER (October 12, 1984)
  • K831568 — RELIANCE TEMPO OPHTH. INSTR STAND (June 30, 1983)
  • K820115 — EMMETT IUD THREAD RETREIVER (February 5, 1982)
  • K811761 — THE EMMETT IUD THREAD RETRIEVER (September 21, 1981)

FDA data resources