510(k) K201135

Device: Image1 S CCU, Image1 S 4U Camera Head
Applicant: KARL STORZ Endoscopy-America, Inc.
510(k) number: K201135
Product code: FET
Decision: Substantially Equivalent (SESE)
Decision date: 2020-09-01
Date received: 2020-04-28
Regulation: 876.1500
Classification name: Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Medical specialty: Gastroenterology, Urology
Review panel: Gastroenterology, Urology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Related Records

Applicant Contact

Contact: Alita McElroy
Address: 2151 E. Grand Ave. El Segundo CA US 90245 90245

FDA Registration Numbers

3024021261
2024311
9610612
2431166
3009057691
3042225166
3007305485
1000121056
8010047
3011050570
3013687468
3010202439
2936485
3018094310
3015895045
3006161756
3009171251
3016497307
3028058843
3010398867
9611102
3004040397
3003018722
3010220595
3033010858
3004837686
9614434
3010273872
9610773
3015970743
3008386005
2183570
3004091527
3003775006
3011802799
2020550
3002808148
3036978610
3014644276
8010418
3016762717
9610595
3015807001
1017294
2027009
3015612252
3043152784
3020746799
3004644065
9610691
3005099803
3021246306
3015515531
2183911
3038132878
3015531529
3006786907
1643264
3012843412
9681260
3009453258
3022106566
9615782
3007695959
3013247477
3012322232
3012797688
9612074
3041659934
9610877
9615393
3017896224
3010707607
3003637092
9610617
3003782610
3014342096
8010298
3013440400
8043903

Source Documents

510(k) summary PDF

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K221174	Telepack +	Karl Storz Endoscopy America, Inc.	2022-05-13
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K202646	Visera Elite II Video System Center	Olympus Medical Systems Corp.	2020-10-29
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