510(k) K090156

Device: ISOLYSER SHARPS ROOM SYSTEM, MODEL 800; ISOLYSER SHARPS MANAGEMENT SYSTEM, MODELS 2400, 4000, 10000
Applicant: WCM WASTE & COMPLIANCE MANAGEMENT, INC.
510(k) number: K090156
Product code: FMI
Decision: Substantially Equivalent (SESE)
Decision date: 2009-09-01
Date received: 2009-01-22
Regulation: 880.5570
Classification name: Needle, Hypodermic, Single Lumen
Medical specialty: General Hospital
Review panel: General Hospital
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Related Records

Applicant Contact

Contact: SARA BETH WATSON
Address: 1330 Connecticut Ave., NW Washington DC US 20036 20036

FDA Registration Numbers

1222780
3004468406
1423537
3016685880
1221765
1063851
3012187743
3019012929
1000484830
8041145
3009761558
3034669683
3021169199
3014747754
9611446
2183771
3003974574
3015997711
3008381300
8040619
3004054016
2433012
3013633270
1054241
1928237
3006380458
3004192065
9612057
3020831613
3009756327
1410248
3007508552
3029755538
9681835
3008729892
2032810
1721183
9610847
9610825
9681821
1220477
3021286079
3015176914
3010055973
3007766601
3010160527
3014570560
3010864832
1450743
3022699058
2243072
3007344957
1036836
9616074
9614868
1820334
1213809
3010377171
3004961578
1417485
9612030
1061124
1526863
3012410077
3017509841
1017768
3029901632
3006371704
3030733800
3016904853
2320762
3005798905
3015140199
3012104670
3013481097
3008102042
9611680
3017494520
3015724078

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DI	Brand	Company	Published
10858629005039	Isolyser/SMS	WCM WASTE & COMPLIANCE MANAGEMENT INC	2016-09-12
10858629005022	Isolyser/SMS	WCM WASTE & COMPLIANCE MANAGEMENT INC	2016-09-12
10858629005015	Isolyser/SMS	WCM WASTE & COMPLIANCE MANAGEMENT INC	2016-09-12
20858629005005	Isolyser/SMS	WCM WASTE & COMPLIANCE MANAGEMENT INC	2016-09-12

Other 510(k) Records For Product Code FMI

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K253047	PRESSONE	Nipro Medical Corporation	2026-03-24
K253622	Safety Pen Needle	Ningbo Medsun Medical Co., Ltd.	2026-03-18
K252886	Pen Needle	Hh Global Technology, Inc.	2026-01-06
K250700	Pen Injector Needle 32.5	Terumo Corporation	2025-11-21
K252631	Profoject Disposable Needle	CMT Health PTE., Ltd.	2025-10-16
K250724	Intraosseous Infusion Needles	Spectrum Vascular	2025-07-30
K250284	TSK SELECT Needle	Tsk Laboratory, Japan	2025-07-24
K251447	K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)	Terumo Europe N.V.	2025-07-08
K243309	27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)	Terumo Europe N.V.	2025-05-29
K240355	FROG (Filter Removal of Glass)	Carrtech Corp	2025-04-18
K243581	K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)	Terumo Europe N.V.	2025-04-04
K250658	SureFine Pen Needle	Shina Med Corporation	2025-04-03
K243806	Safety Winged Blood Collection Sets	Promisemed Hangzhou Meditech Co., Ltd.	2025-01-10

Legacy Summary

summary

FDA Review

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