Data / Medical devices / United States / Santa Barbara Imaging Systems

Santa Barbara Imaging Systems: FDA-registered device maker in Goleta, CA, United States, 14 510(k) clearances

Name: Santa Barbara Imaging Systems FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Santa Barbara Imaging Systems is registered with the FDA (registration 3011373951) in Goleta, CA, United States. It lists 12 device types. The FDA files 14 510(k) clearances under its listings, the newest dated February 28, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3011373951
Address: 340 Storke Rd Ste 101, Goleta, CA, United States, 93117
Owner or operator: Santa Barbara Imaging Systems (10048981)
Roles: Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
First device listed: March 27, 2015
Registered through: 2026

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Arthroscopic	NBH	1	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Accessories, Photographic, For Endoscope (Exclude Light Sources)	FEM	1	Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Accessory Equipment, Cardiopulmonary Bypass	KRI	1	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Adaptor, Bulbs, Miscellaneous, For Endoscope	FFY	1	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Arthroscope	HRX	2	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Camera, Surgical And Accessories	KQM	1	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Camera, Television, Surgical, With Audio	FWC	1	Contract manufacturer, Manufacturer, Specification developer	accessdata.fda.gov
Cart, Emergency, Cardiopulmonary (Excluding Equipment)	BZN	1	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Light, Surgical, Fiberoptic	FST	2	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	KCT	2	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
System, Digital Image Communications, Radiological	LMD	1	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 28, 2023	K223116	8X-10-6XXX Camera Head	GCJ	Substantially Equivalent	Santa Barbara Imaging Systems	accessdata.fda.gov
December 15, 2015	K152513	8X-10-XXXX Camera System	GCJ	Substantially Equivalent	Santa Barbara Imaging Systems	accessdata.fda.gov
August 18, 2015	K151166	Instru-Safe Instrument Protection System	KCT	Substantially Equivalent	Summit Medical, Inc.	accessdata.fda.gov
June 22, 2015	K150540	Instru-Safe Instrument Protection System	KCT	Substantially Equivalent	Summit Medical, Inc.	accessdata.fda.gov
May 29, 2015	K142768	Instru-Safe Instrument Protection System	KCT	Substantially Equivalent	Summit Medical, Inc.	accessdata.fda.gov
December 23, 2014	K142630	Instru-Safe Instrument Protection System	KCT	Substantially Equivalent	Summit Medical, Inc.	accessdata.fda.gov
December 15, 2014	K141513	INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM	KCT	Substantially Equivalent	Summit Medical, Inc.	accessdata.fda.gov
June 27, 2014	K140289	INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM	KCT	Substantially Equivalent	Summit Medical, Inc.	accessdata.fda.gov
March 13, 2014	K133015	INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM	KCT	Substantially Equivalent	Summit Medical, Inc.	accessdata.fda.gov
March 18, 2008	K080560	HENKE SASS WOLF OF AMERICA ARTHROSCOPE	HRX	Substantially Equivalent	Henke Sass Wolf of America, Inc.	accessdata.fda.gov
September 1, 2005	K051157	INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMS	KCT	Substantially Equivalent	Micromedics, Inc.	accessdata.fda.gov
March 24, 2005	K050163	HENKE SASS WOLF OF AMERICA BARIATRIC LAPAROSCOPE	GCJ	Substantially Equivalent	Henke Sass Wolf of America, Inc.	accessdata.fda.gov
May 16, 1994	K941541	HSV LAPAROSCOPY SET	GCJ	Substantially Equivalent	Henke Sass Wolf of America, Inc.	accessdata.fda.gov
April 23, 1990	K901035	FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLE	FST	Substantially Equivalent	Cuda Products Co.	accessdata.fda.gov

Compare with other makers

Updated February 28, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.