510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K971277Substantially Equivalent

Safe-T-Clamp

Talon Medical, Ltd., San Antonio TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971277 is the FDA 510(k) clearance record for SAFE-T-CLAMP, a class II device, cleared for Talon Medical, Ltd. on under FDA product code KNA (Instrument, Manual, Specialized Obstetric-Gynecologic). FDA records list one 510(k) clearance for Talon Medical, Ltd. As of , FDA records show no recalls naming K971277.

Clearance record

Decision date
Received
(43 days to decision)
Product code
KNA Instrument, Manual, Specialized Obstetric-Gynecologic
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Talon Medical, Ltd. 18160 Hwy., 281 N.,#108-200, San Antonio TX
510(k) summary
Statement
Third party review
No

Clearances, product code KNA

Trailing 12 months

FDA records hold no clearances under product code KNA in the trailing twelve months.

FDA records show no clearances under product code KNA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KNA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260