510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K063429Substantially Equivalent

Gmd Universal Circumcision Clamp, Model 200

Generic Medical Device, Inc., Houston TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063429 is the FDA 510(k) clearance record for GMD UNIVERSAL CIRCUMCISION CLAMP, MODEL 200, a class II device, cleared for Generic Medical Device, Inc. on under FDA product code HFX (Clamp, Circumcision). FDA records list 4 510(k) clearances for Generic Medical Device, Inc., from to . As of , FDA records show no recalls naming K063429.

Clearance record

Decision date
Received
(65 days to decision)
Product code
HFX Clamp, Circumcision
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Generic Medical Device, Inc. 3906 Roseland St., Houston TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HFX

Trailing 12 months
1 clearance under product code HFX in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HFX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260