Atlas FDA

GENERAL PROCEDURE KIT

FDA 510(k) clearance K960248 · decided 1996-04-12

Clearance details

K-number
K960248
Device name
GENERAL PROCEDURE KIT
Applicant
Physician Industries, Inc.
Decision
Substantially Equivalent
Date received
1996-01-16
Decision date
1996-04-12
Days to decision
87 days
Clearance type
Traditional
Product code
FMF
Device class
2
Regulation number
880.5860
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
North Salt Lake, UT, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Integra Bone Marrow Biopsy Trays Catalogue No. 3404253 Various medical devices and compone recall (Z-0193-2016)Integra LifeSciences Corp. d.b.a. Integra Pain Management2015-10-30
Integra Pain Management Disposable, Convenience Kit PICC INSERTION TRAY, Reorder Number 34 recall (Z-2575-2011)Integra LifeSciences Corp.2011-06-22
Integra Pain Management Disposable, Convenience Kit PICC INSERTION TRAY, Reorder Number 10 recall (Z-2576-2011)Integra LifeSciences Corp.2011-06-22
Nerve Block Tray, Disposable, Convenience Kit, Reorder Number DYNJTS0382B, Integra LifeSci recall (Z-2079-2009)Integra Life Sciences Corporation2009-09-21
Universal Block Tray, Disposable, Convenience Tray, Reorder Number CUS1407-06, Integra Lif recall (Z-2080-2009)Integra Life Sciences Corporation2009-09-21
Nerve Block Tray, Disposable, Convenience Kit, Reorder Number CUS1234, Integra LifeScience recall (Z-2081-2009)Integra Life Sciences Corporation2009-09-21
Single Shot Epidural Tray, Disposable Convenience Kit, Reorder Number CUS1474-01, Integra recall (Z-2082-2009)Integra Life Sciences Corporation2009-09-21
Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number 10-2378, Integra Li recall (Z-2083-2009)Integra Life Sciences Corporation2009-09-21
Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS511-08, Integra recall (Z-2085-2009)Integra Life Sciences Corporation2009-09-21
Universal Block Tray, Disposable, Convenience Kit, Reorder Number CUS1736-02, Integra Life recall (Z-2086-2009)Integra Life Sciences Corporation2009-09-21
Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS1729-01, Integra recall (Z-2087-2009)Integra Life Sciences Corporation2009-09-21
Block Tray, Disposable, Convenience Kit, Reorder Number CUS835, Integra LifeSciences Corpo recall (Z-2088-2009)Integra Life Sciences Corporation2009-09-21
Biopsy Tray (BMTX-1039), Disposable, Convenience Kit, Reorder Number CUS1189, Integra Life recall (Z-2089-2009)Integra Life Sciences Corporation2009-09-21
Nerve Block Tray, Disposable, Convenience Kit, Reorder Number CUS1044-02, Integra LifeScie recall (Z-2090-2009)Integra Life Sciences Corporation2009-09-21
Tuohy Needle, 20G X 3.5", Removable Wing, Plastic Hub, Metal Stylet, Calibrations (10BX), recall (Z-2091-2009)Integra Life Sciences Corporation2009-09-21
Custom Procedure Tray, Disposable, Convenience Kit, Reorder Number CUS015-01, Integra Life recall (Z-2092-2009)Integra Life Sciences Corporation2009-09-21
Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number SS1453, Integra Lif recall (Z-2093-2009)Integra Life Sciences Corporation2009-09-21
Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS1427, Integra Li recall (Z-2094-2009)Integra Life Sciences Corporation2009-09-21
Nerve Block Tray, Disposable, Convenience Kit, Reorder Number 10-2527, Integra LifeScience recall (Z-2095-2009)Integra Life Sciences Corporation2009-09-21
Universal Block Tray, Disposable, Convenience Kit, Reorder Number CUS651, Integra LifeScie recall (Z-2096-2009)Integra Life Sciences Corporation2009-09-21
Extension Set Pack, Disposable, Convenience Kit, Reorder Number CUS994, Integra LifeScienc recall (Z-2097-2009)Integra Life Sciences Corporation2009-09-21
CHIBA Spinal 22G X 3.50, Plastic Hub, Metal Stylet, Disposable, Convenience Kit, Reorder N recall (Z-2098-2009)Integra Life Sciences Corporation2009-09-21
Epidural Catheter Pack with Stylet, Disposable, Convenience Kit, Reorder Number CA20CES, I recall (Z-2099-2009)Integra Life Sciences Corporation2009-09-21
Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS1722-01, Integra recall (Z-2100-2009)Integra Life Sciences Corporation2009-09-21
Universal Painpak, Disposable, Convenience Kit, Reorder Number SS3278, Integra LifeScience recall (Z-2101-2009)Integra Life Sciences Corporation2009-09-21
South Texas Pain Tray, Disposable, Convenience Kit, Reorder Number CUS1308-01, Integra Lif recall (Z-2102-2009)Integra Life Sciences Corporation2009-09-21
Universal Block Tray, Disposable, Convenience Kit, Reorder Number CUS1619, Integra LifeSci recall (Z-2103-2009)Integra Life Sciences Corporation2009-09-21
Universal Block Tray, Disposable, Convenience Kit, Reorder Number CUS1756, Integra LifeSci recall (Z-2104-2009)Integra Life Sciences Corporation2009-09-21
Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS1593-01, Integra recall (Z-2105-2009)Integra Life Sciences Corporation2009-09-21
Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number SS1719, Integra Lif recall (Z-2106-2009)Integra Life Sciences Corporation2009-09-21
Complete Single Shot Tray, Disposable, Convenience Kit, Reorder Number CUS042, Integra Lif recall (Z-2107-2009)Integra Life Sciences Corporation2009-09-21
Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS185-01, Integra recall (Z-2108-2009)Integra Life Sciences Corporation2009-09-21
Integra LifeSciences Corporation Disposable Convenience Kit, PICC Insertion Tray, CUS791 recall (Z-1635-2008)Integra Pain Management2008-08-14