510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K042555Substantially Equivalent

Surgichip Tag Surgical Marker

Surgichip, Inc., Palm Beach Gardens FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K042555 is the FDA 510(k) clearance record for SURGICHIP TAG SURGICAL MARKER, a class I device, cleared for Surgichip, Inc. on under FDA product code FZZ (Marker, Skin). FDA records list one 510(k) clearance for Surgichip, Inc. As of , FDA records show no recalls naming K042555.

Clearance record

Decision date
Received
(50 days to decision)
Product code
FZZ Marker, Skin
Regulation
21 CFR 878.4660
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Surgichip, Inc. 4398 Hickory Dr., Palm Beach Gardens FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FZZ

Trailing 12 months

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

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