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
K852711Substantially Equivalent

Scalpel Handle #3 Ss 410 or 420

The Huxley Instrument Corp., Penn Yan NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852711 is the FDA 510(k) clearance record for SCALPEL HANDLE #3 SS 410 OR 420, a class I device, cleared for The Huxley Instrument Corp. on under FDA product code GDZ (Handle, Scalpel). FDA records list 53 510(k) clearances for The Huxley Instrument Corp., from to . As of , FDA records show no recalls naming K852711.

Clearance record

Decision date
Received
(19 days to decision)
Product code
GDZ Handle, Scalpel
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
The Huxley Instrument Corp. 215 Main St., Penn Yan NY
Third party review
No

Clearances, product code GDZ

Trailing 12 months

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

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