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
K831773Substantially Equivalent

Mai Hydroseal Implant for Scleral Buck

Bcd Products, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K831773 is the FDA 510(k) clearance record for MAI HYDROSEAL IMPLANT FOR SCLERAL BUCK, a class II device, cleared for Bcd Products, Inc. on under FDA product code HQJ (Implant, Absorbable, (Scleral Buckling Methods)). FDA records list 2 510(k) clearances for Bcd Products, Inc., from to . As of , FDA records show no recalls naming K831773.

Clearance record

Decision date
Received
(75 days to decision)
Product code
HQJ Implant, Absorbable, (Scleral Buckling Methods)
Regulation
21 CFR 886.3300
Device class
Class II
Review panel
Ophthalmic
Applicant
Bcd Products, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code HQJ

Trailing 12 months

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

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