Atlas FDA

OASYS SURGICAL LIGHT CONTROLLER

FDA 510(k) clearance K112133 · decided 2012-03-01

Clearance details

K-number
K112133
Device name
OASYS SURGICAL LIGHT CONTROLLER
Applicant
Oasys Healthcare
Decision
Substantially Equivalent
Date received
2011-07-26
Decision date
2012-03-01
Days to decision
219 days
Clearance type
Traditional
Product code
FTA
Device class
2
Regulation number
878.4580
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Appollo Beach, FL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Universal Light Handle Cover, Light Handle Cover (K150532)Key Surgical, Inc.2015-09-22
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SURGICAL LIGHT HANDLE COVER (K133554)Microtek Medical, Inc. an Ecolab Company2014-04-08
IDSS SLC (K133413)Black Diamond Video2014-01-07
EASYSUITE SURGICAL LIGHT CONTROL (ESLC) (K102791)Image Stream Medical, Inc.2010-11-23
MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC) (K081698)Image Stream Medical, Inc.2008-07-30
LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER (K053321)Xodus Medical, Inc.2006-01-19
SCB/STERIS OR-LIGHT INTERFACE BOX (K051505)KARL STORZ Endoscopy-America, Inc.2005-08-11
KSEA SCB ACC CONTROL (K023704)KARL STORZ Endoscopy-America, Inc.2003-01-30
KSEA SCB MEDIA CONTROL (K020640)KARL STORZ Endoscopy-America, Inc.2002-05-28
DISPOSABLE LIGHT HANDLE AND ADAPTOR (K020304)Aspen Surgical Products, Inc.2002-02-14
DEROYAL DISPOSABLE RIGID LIGHT HANDLE AND ADAPTER (K993089)Deroyal Cardiovascular, Inc.1999-10-14

Recalls involving this device

No recalls on record reference this clearance.