510(k) K153337
- Device
- Corvocet Biopsy System
- Applicant
- MERIT MEDICAL SYSTEMS, INC.
- 510(k) number
- K153337
- Product code
- KNW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-03-25
- Date received
- 2015-11-19
- Regulation
- 876.1075
- Classification name
- Instrument, Biopsy
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Ileana Davis
- Address
- 1600 W. Merit Pkwy. South Jordan UT US 84095 84095
FDA Registration Numbers
- 1423662
- 1450662
- 3006788678
- 1825146
- 3038356900
- 3007200016
- 3022977243
- 1423507
- 1221485
- 3015980719
- 9617592
- 1061124
- 2027062
- 3001592626
- 1222168
- 1037885
- 3012536737
- 3013188547
- 3009077524
- 3007513241
- 3004122598
- 3007137598
- 2320767
- 1644312
- 3018507299
- 2032098
- 3004598644
- 3016688836
- 3005636544
- 3006063136
- 3015142721
- 3015806723
- 3003500271
- 2649614
- 3030447506
- 2648727
- 3011504993
- 3013557562
- 2246552
- 1123169
- 2133772
- 3012936513
- 1319660
- 1423537
- 1721676
- 3015219237
- 3010515547
- 1820334
- 3007664053
- 3033589330
- 3006950086
- 9611680
- 3004749705
- 3008992312
- 3017210488
- 3017636737
- 3007648417
- 3008773560
- 3012495575
- 9611612
- 1018233
- 1417485
- 3009423112
- 3004636440
- 3030733800
- 3013875526
- 3010331645
- 1625425
- 3027269340
- 3014032451
- 3030626857
- 3010097171
- 1835568
- 3015231789
- 3002808022
- 3014279513
- 1000484830
- 1056129
- 1649518
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 20884450373501 | CorVocet™ | Merit Medical Systems, Inc. | 2018-09-13 |
| 10884450373597 | CorVocet™ | Merit Medical Systems, Inc. | 2018-01-22 |
| 10884450373825 | CorVocet™ | Merit Medical Systems, Inc. | 2018-01-22 |
| 20884450373808 | CorVocet™ | Merit Medical Systems, Inc. | 2018-01-22 |
| 10884450373894 | CorVocet™ | Merit Medical Systems, Inc. | 2018-01-22 |
| 20884450373907 | CorVocet™ | Merit Medical Systems, Inc. | 2018-01-22 |
| 10884450373924 | CorVocet™ | Merit Medical Systems, Inc. | 2018-01-22 |
| 10884450373931 | CorVocet™ | Merit Medical Systems, Inc. | 2018-01-22 |
| 10884450373948 | CorVocet™ | Merit Medical Systems, Inc. | 2018-01-22 |
| 10884450373955 | CorVocet™ | Merit Medical Systems, Inc. | 2018-01-22 |
| 20884450373976 | CorVocet™ | Merit Medical Systems, Inc. | 2018-01-22 |
| 20884450373761 | CorVocet™ | Merit Medical Systems, Inc. | 2018-01-22 |
| 20884450373884 | CorVocet™ | Merit Medical Systems, Inc. | 2018-01-22 |
| 20884450373631 | CorVocet™ | Merit Medical Systems, Inc. | 2018-01-22 |
| 20884450373624 | CorVocet™ | Merit Medical Systems, Inc. | 2018-01-22 |
| 20884450373617 | CorVocet™ | Merit Medical Systems, Inc. | 2018-01-22 |
| 10884450373962 | CorVocet™ | Merit Medical Systems, Inc. | 2018-01-22 |
| 10884450373580 | CorVocet™ | Merit Medical Systems, Inc. | 2018-01-22 |
| 10884450373573 | CorVocet™ | Merit Medical Systems, Inc. | 2018-01-22 |
| 10884450373566 | CorVocet™ | Merit Medical Systems, Inc. | 2018-01-22 |
| 20884450373556 | CorVocet™ | Merit Medical Systems, Inc. | 2018-01-22 |
| 10884450373542 | CorVocet™ | Merit Medical Systems, Inc. | 2018-01-22 |
| 10884450373535 | CorVocet™ | Merit Medical Systems, Inc. | 2018-01-22 |
| 10884450373528 | CorVocet™ | Merit Medical Systems, Inc. | 2018-01-22 |
| 20884450373518 | CorVocet™ | Merit Medical Systems, Inc. | 2018-01-22 |
| 10884450373498 | CorVocet™ | Merit Medical Systems, Inc. | 2018-01-22 |
| 10884450373474 | CorVocet™ | Merit Medical Systems, Inc. | 2018-01-22 |
| 20884450373457 | CorVocet™ | Merit Medical Systems, Inc. | 2018-01-22 |
| 10884450373443 | CorVocet™ | Merit Medical Systems, Inc. | 2018-01-22 |
| 20884450373433 | CorVocet™ | Merit Medical Systems, Inc. | 2018-01-22 |
Legacy Summary
summary
FDA Review
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