510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K820730Substantially Equivalent

Micro Cise Diamond Scalpel

CooperVision, Inc., Southampton, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K820730 is the FDA 510(k) clearance record for MICRO CISE DIAMOND SCALPEL, a class I device, cleared for CooperVision, Inc. on under FDA product code GDX (Scalpel, One-Piece). FDA records list 97 510(k) clearances for CooperVision, Inc., from to . As of , FDA records show no recalls naming K820730.

Clearance record

Decision date
Received
(23 days to decision)
Product code
GDX Scalpel, One-Piece
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
CooperVision, Inc. Permalens House, Southampton, GB
Third party review
No

Clearances, product code GDX

Trailing 12 months

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

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