510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K921633Substantially Equivalent

Ors-2000 Series

Mnlase, Inc., Reston VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921633 is the FDA 510(k) clearance record for ORS-2000 SERIES, a class I device, cleared for Mnlase, Inc. on under FDA product code LHC (Warmer, Irrigation Solution). FDA records list 22 510(k) clearances for Mnlase, Inc., from to . As of , FDA records show no recalls naming K921633.

Clearance record

Decision date
Received
(57 days to decision)
Product code
LHC Warmer, Irrigation Solution
Regulation
21 CFR 890.5950
Device class
Class I
Review panel
Physical Medicine
Applicant
Mnlase, Inc. 11250 Roger Bacon Dr. #10, Reston VA
510(k) summary
Statement
Third party review
No

Clearances, product code LHC

Trailing 12 months

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

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