510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K896998Substantially Equivalent

Atrauclip (Tantalum Hemostatic Clip)

S.P.K. Technology, Inc., Seal Beach CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K896998 is the FDA 510(k) clearance record for ATRAUCLIP (TANTALUM HEMOSTATIC CLIP), a class II device, cleared for S.P.K. Technology, Inc. on under FDA product code MCH (Clip, Hemostatic). FDA records list 2 510(k) clearances for S.P.K. Technology, Inc., from to . As of , FDA records show no recalls naming K896998.

Clearance record

Decision date
Received
(171 days to decision)
Product code
MCH Clip, Hemostatic
Regulation
21 CFR 878.4300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
S.P.K. Technology, Inc. 321 Regatta Way, Seal Beach CA
Third party review
No

Clearances, product code MCH

Trailing 12 months

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

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