Atlas FDA

POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIMULATION NEEDLE

FDA 510(k) clearance K990100 · decided 2000-08-02

Clearance details

K-number
K990100
Device name
POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIMULATION NEEDLE
Applicant
Te ME NA S.A.R.L.
Decision
Substantially Equivalent
Date received
1999-01-04
Decision date
2000-08-02
Days to decision
576 days
Clearance type
Traditional
Product code
GXZ
Device class
2
Regulation number
882.1350
Medical specialty
Neurology
Advisory committee
Neurology
Location
Oldsmar, FL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
21G x 90mm/20 Bevel Single Shot Needle, REF 55-021-090, Rx, Sterile, Distributed by: Stryk recall (Z-2361-2010)Stryker Instruments Div. of Stryker Corporation2010-09-03
22G x 50m/20 bevel Single Shot Needle, REF 552-022-050, Rx, Sterile, Distributed by: Stryk recall (Z-2362-2010)Stryker Instruments Div. of Stryker Corporation2010-09-03
21G x 150m/20 bevel Single Shot Needle, REF 552-021-150, Rx, Sterile, Distributed by: Stry recall (Z-2363-2010)Stryker Instruments Div. of Stryker Corporation2010-09-03
22G x 70mm/20 bevel Single Shot Needle, REF 552-022-70, Rx, Sterile, Distributed by: Stryk recall (Z-2364-2010)Stryker Instruments Div. of Stryker Corporation2010-09-03
24G x 25mm/20 bevel Single Shot Needle, REF 552-024-025, Rx, Sterile, Distributed by: Stry recall (Z-2365-2010)Stryker Instruments Div. of Stryker Corporation2010-09-03
18G x 50mm/20 Tuohy Catheter Kit, REF 553-118-050, Rx, Sterile, Distributed by: Stryker In recall (Z-2366-2010)Stryker Instruments Div. of Stryker Corporation2010-09-03
18G x 90mm/20 Tuohy Catheter Kit, REF 553-118-090, Rx, Sterile, Distributed by: Stryker In recall (Z-2367-2010)Stryker Instruments Div. of Stryker Corporation2010-09-03
18G x 150m Tuohy Catheter Kit, REF 553-118-150, Rx, Sterile, Distributed by: Stryker Instr recall (Z-2368-2010)Stryker Instruments Div. of Stryker Corporation2010-09-03
17G x 50m Tuohy Catheter Kit, REF 553-218-50, Rx, Sterile, Distributed by: Stryker Instrum recall (Z-2369-2010)Stryker Instruments Div. of Stryker Corporation2010-09-03
17G x 90m Tuohy Stimulation Catheter Kit, REF 553-218-90, Rx, Sterile, Distributed by: Str recall (Z-2370-2010)Stryker Instruments Div. of Stryker Corporation2010-09-03
17G x 150mm Tuohy Stimulation Catheter Kit, REF 553-218-150, Rx, Sterile, Distributed by: recall (Z-2371-2010)Stryker Instruments Div. of Stryker Corporation2010-09-03
17G x 150mm Stimulation Catheter Continuous Nerve Block Tray, REF 553-318-050, Rx, Sterile recall (Z-2372-2010)Stryker Instruments Div. of Stryker Corporation2010-09-03
17G x 90mm Stimulation Catheter Continuous Nerve Block Tray, REF 553-318-090, Rx, Sterile, recall (Z-2373-2010)Stryker Instruments Div. of Stryker Corporation2010-09-03
17G x 150mm Stimulation Catheter Continuous Nerve Block Tray, REF 553-318-150, Rx, Sterile recall (Z-2374-2010)Stryker Instruments Div. of Stryker Corporation2010-09-03
21G x 90mm/45 Bevel Single Shot Needle, REF 554-021-090, Rx, Sterile, Distributed by: Stry recall (Z-2375-2010)Stryker Instruments Div. of Stryker Corporation2010-09-03
21G x 150mm Stimulation Catheter Continuous Nerve Block Tray, REF 554-021-150, Rx, Sterile recall (Z-2376-2010)Stryker Instruments Div. of Stryker Corporation2010-09-03
22G x 50mm/45 Bevel Single Shot Needle, REF 554-022-050, Rx, Sterile, Distributed by: Stry recall (Z-2377-2010)Stryker Instruments Div. of Stryker Corporation2010-09-03
22G x 70mm/45 Bevel Single Shot Needle, REF 554-022-070, Rx, Sterile, Distributed by: Stry recall (Z-2378-2010)Stryker Instruments Div. of Stryker Corporation2010-09-03
24G x 25mm/45 Bevel Single Shot Needle, REF 554-024-025, Rx, Sterile, Distributed by: Stry recall (Z-2379-2010)Stryker Instruments Div. of Stryker Corporation2010-09-03