510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K941972Substantially Equivalent

Hemo-O-Lok

King & Spalding, Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K941972 is the FDA 510(k) clearance record for HEMO-O-LOK, a class II device, cleared for King & Spalding on under FDA product code FZP (Clip, Implantable). FDA records list 7 510(k) clearances for King & Spalding, from to . As of , FDA records show no recalls naming K941972.

Clearance record

Decision date
Received
(68 days to decision)
Product code
FZP Clip, Implantable
Regulation
21 CFR 878.4300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
King & Spalding 1730 Pennsylvania Ave., NW, Washington DC
510(k) summary
Statement
Third party review
No

Clearances, product code FZP

Trailing 12 months
5 clearances under product code FZP in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FZP, trailing twelve months
MonthClearances
November 20251
December 20252
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20261
October 20260