510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K810045Substantially Equivalent

I.m. Retrograde Blades

Hogan & Hartson, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K810045 is the FDA 510(k) clearance record for I.M. RETROGRADE BLADES, a class I device, cleared for Hogan & Hartson on under FDA product code GFA (Blade, Saw, General & Plastic Surgery, Surgical). FDA records list 26 510(k) clearances for Hogan & Hartson, from to . As of , FDA records show no recalls naming K810045.

Clearance record

Decision date
Received
(35 days to decision)
Product code
GFA Blade, Saw, General & Plastic Surgery, Surgical
Regulation
21 CFR 878.4820
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Hogan & Hartson 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GFA

Trailing 12 months

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

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