510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K905460Substantially Equivalent

Sterile Disposable Drape/ophthalmic Surgery

Angiosystems, Inc., Great Neck NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K905460 is the FDA 510(k) clearance record for STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERY, a class II device, cleared for Angiosystems, Inc. on under FDA product code HMT (Drape, Patient, Ophthalmic). FDA records list 14 510(k) clearances for Angiosystems, Inc., from to . As of , FDA records show no recalls naming K905460.

Clearance record

Decision date
Received
(63 days to decision)
Product code
HMT Drape, Patient, Ophthalmic
Regulation
21 CFR 878.4370
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Angiosystems, Inc. C/O Medical Device Inspeciton, Great Neck NY
Third party review
No

Clearances, product code HMT

Trailing 12 months

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

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