510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Karl Storz Imaging, Inc.

Goleta, CA, US

KARL STORZ IMAGING, INC. appears in FDA device records in Goleta, CA. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
10
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 10 510(k) clearances for Karl Storz Imaging, Inc. between 1995 and 2001. The busiest year on record is 1995, with 3. The most recent is 2001, with 1.

Clearances by year, as a table
510(k) clearance decisions for Karl Storz Imaging, Inc., by decision year
YearClearances
19953
19961
19971
19981
19991
20002
20011
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K003325KSI'S NEW CAMERA ARCHITECTURE (NCA) VIDEO IMAGING SYSTEMFETSubstantially Equivalent
K001362KARL STORZ 3D VIDEO SYSTEMGCISubstantially Equivalent
K994090KARL STORZ AUTOCLAVABLE CAMERA HEADFETSubstantially Equivalent
K990154KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEMFWFSubstantially Equivalent
K974391KARL STORZ ENDOVISION XL ENDOSCOPIC CAMERA SYSTEMGCJSubstantially Equivalent
K973252KARL STORZ DIRECT COUPLED CAMERA HEADFETSubstantially Equivalent
K963333OPTRONICS EPIC COLOR TELEVISION CAMERA SYSTEM (S97340)HKISubstantially Equivalent
K950862KARL STORZ ENDOVISION TRICAM, MODEL 20221101 (20221001, PAL FORMAT) COLOR TELEVISION CAMERA FOR ENDOSCOPIC PROCEDURESGCJSubstantially Equivalent
K950975KARL STORZ ENDOVISION TWINVIDEO (DIGITAL PICTURE-IN-PICTURE PROCESSOR) ACCESSORY FOR COLOR TELEVISION CAMERA USED IN ENSFETSubstantially Equivalent
K950974KARL STORZ ENDOVISION DIGIVIDEO (DIGITAL IMAGE PROCESSOR) ACCESSORY FOR COLOR TELEVISION CAMERA USED IN ENDOSCOPIC PROCSFETSubstantially Equivalent

Registered establishments

FDA registered establishments for Karl Storz Imaging, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
20270092027009KARL STORZ IMAGING, INC.1 S Los Carneros Rd, Goleta, CA 93117 US2026and 6 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain