ORS-1000LD— 510(k) K021288

Clearance details

Applicant

O.R. Solutions, Inc.

Product code

Code LHC

Device class

Class 1

Regulation

21 CFR 890.5950

Advisory panel

Physical Medicine

Date received

2002-04-23

Decision date

2002-06-27

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Chantilly, VA, US

• K153713 — Getinge Series Warming Cabinet2016-06-07
• K152522 — ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes2016-01-15
• K150190 — IntraTemp Solution Warmer2015-02-26
• K142173 — NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE2014-12-30
• K142080 — NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED2014-08-28

• K051979 — ORS MODEL 6000 ENDOSCOPE HOLDER2005-08-30
• K023282 — ORS-3000LD2002-11-13
• K023283 — 1075LD HUSH-SLUSH2002-11-13
• K021289 — WARMER 2000LD2002-06-26
• K960836 — DMS-90001996-09-12

• Z-2793-2015 — Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.Class II·Terminated·Ecolab Inc·20150818

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K021288.