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
K896473Substantially Equivalent

H200 Hanna Suction Trephine System for Corneal Sur

Emory University School of Medicine, Atlanta GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K896473 is the FDA 510(k) clearance record for H200 HANNA SUCTION TREPHINE SYSTEM FOR CORNEAL SUR, a class I device, cleared for Emory University School of Medicine on under FDA product code HPN (Magnet, Permanent). FDA records list one 510(k) clearance for Emory University School of Medicine. As of , FDA records show no recalls naming K896473.

Clearance record

Decision date
Received
(88 days to decision)
Product code
HPN Magnet, Permanent
Regulation
21 CFR 886.4445
Device class
Class I
Review panel
Ophthalmic
Applicant
Emory University School of Medicine 1327 Clifton Rd., NE, Atlanta GA
Third party review
No

Clearances, product code HPN

Trailing 12 months

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

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