510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K924148Substantially Equivalent

Diamond-Sharp(r) Trocars

Snowden-Pencer, Tucker GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K924148 is the FDA 510(k) clearance record for DIAMOND-SHARP(R) TROCARS, a class II device, cleared for Snowden-Pencer on under FDA product code HFI (Coagulator, Culdoscopic (And Accessories)). FDA records list 11 510(k) clearances for Snowden-Pencer, from to . As of , FDA records show no recalls naming K924148.

Clearance record

Decision date
Received
(559 days to decision)
Product code
HFI Coagulator, Culdoscopic (And Accessories)
Regulation
21 CFR 884.4160
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Snowden-Pencer 5175 S. Royal Atlanta Dr., Tucker GA
510(k) summary
Statement
Third party review
No

Clearances, product code HFI

Trailing 12 months

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

FDA records show no clearances under product code HFI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HFI, 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