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510(k) K926535

GOMCO CIRCUMCISION CLAMP by Thomasville Medical Assoc. — Product Code HFX

K926535 is an FDA 510(k) premarket notification submitted by Thomasville Medical Assoc. for the device "GOMCO CIRCUMCISION CLAMP". The FDA issued a decision of Substantially Equivalent on February 25, 1994. The device falls under product code HFX (Clamp, Circumcision), a Class II 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 25, 1994
Date Received
December 30, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Circumcision
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances by Thomasville Medical Assoc.

  • K926429 — VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT (February 28, 1994)
  • K926540 — SOPHER AND BIERER OVUM FORCEPS (February 25, 1994)
  • K926531 — HYSTERECTOMY FORCEPS (February 25, 1994)
  • K926532 — ENDO CERVICAL CURETTE (February 25, 1994)
  • K926471 — MOGAN CIRCUMCISION CLAMP (February 25, 1994)
  • K926527 — ROTO FIT BIOPSY 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 HFX

  • K251687 — Konig Bell Circumcision Clamp (February 25, 2026)
  • K221356 — Wee Bell (February 2, 2023)
  • K212911 — Konig Mogen Clamp (November 18, 2022)
  • K151095 — Circumplast Circumcision Device (September 18, 2015)
  • K142163 — MALE CIRCUMCISION KITS:RAPIDECLAMP (April 20, 2015)
  • K131373 — SHANGRING (June 25, 2013)
  • K121789 — SHANGRING (August 3, 2012)
  • K103695 — PREPEX SYSTEM (January 10, 2012)
  • K100916 — MEDICON MOGEN CLAMP (December 6, 2010)
  • K061539 — GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE (September 20, 2007)

FDA data resources