510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K770541Substantially Equivalent

Scissors, Surgical, 12.5,14,16 & 18 Cm.

Sea-Pac Trading Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K770541 is the FDA 510(k) clearance record for SCISSORS, SURGICAL, 12.5,14,16 & 18 CM., a class I device, cleared for Sea-Pac Trading Corp. on under FDA product code FZT (Cutter, Surgical). FDA records list 7 510(k) clearances for Sea-Pac Trading Corp. As of , FDA records show no recalls naming K770541.

Clearance record

Decision date
Received
(25 days to decision)
Product code
FZT Cutter, Surgical
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Sea-Pac Trading Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FZT

Trailing 12 months

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

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