510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K770428Substantially Equivalent

Various Surg. & Diagnostic Instru. Etc.

Holco Instrument Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K770428 is the FDA 510(k) clearance record for VARIOUS SURG. & DIAGNOSTIC INSTRU. ETC., a class I device, cleared for Holco Instrument Corp. on under FDA product code FSM (Tray, Surgical, Instrument). FDA records list 2 510(k) clearances for Holco Instrument Corp., from to . As of , FDA records show no recalls naming K770428.

Clearance record

Decision date
Received
(919 days to decision)
Product code
FSM Tray, Surgical, Instrument
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Holco Instrument Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FSM

Trailing 12 months

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

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