510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K843890Substantially Equivalent

Custom Instrument Drape

Lifestream Int'L, Inc., Sugar Land TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843890 is the FDA 510(k) clearance record for CUSTOM INSTRUMENT DRAPE, a class II device, cleared for Lifestream Int'L, Inc. on under FDA product code HMW (Drape, Microscope, Ophthalmic). FDA records list 23 510(k) clearances for Lifestream Int'L, Inc., from to . As of , FDA records show no recalls naming K843890.

Clearance record

Decision date
Received
(24 days to decision)
Product code
HMW Drape, Microscope, Ophthalmic
Regulation
21 CFR 878.4370
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Lifestream Int'L, Inc. 525 Julie Rivers Dr., Sugar Land TX
Third party review
No

Clearances, product code HMW

Trailing 12 months

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

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