Atlas FDA

ENVOYCEM, MODEL 1640

FDA 510(k) clearance K080032 · decided 2008-02-28

Clearance details

K-number
K080032
Device name
ENVOYCEM, MODEL 1640
Applicant
Envoy Medical Corporation
Decision
Substantially Equivalent
Date received
2008-01-07
Decision date
2008-02-28
Days to decision
52 days
Clearance type
Traditional
Product code
NEA
Device class
2
Regulation number
872.3275
Medical specialty
Dental
Advisory committee
Dental
Location
St. Paul, MN, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Envoy Medical Corporation

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

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

RecordFirmDate
PROCEM (K140644)Ototronix, LLC2014-06-19
STRYKER INJECTABLE CEMENT (K060750)Stryker Cmf2006-04-19
OTOMIMIX (K042516)Walter Lorenz Surgical, Inc.2004-11-08
OTO-CEM (K011338)Ototech, Inc.2001-09-13
SERENOCEM, MODEL BC 010 (K003567)Corinthian Medical , Ltd.2001-02-12

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Esteem® Totally Implantable Hearing System (P090018/S041)Envoy Medical Corporation2022-08-24
Esteem (P090018/S039)Envoy Medical Corporation2020-02-24
Esteem System (P090018/S038)Envoy Medical Corporation2019-09-26
Esteem Totally Implantable Hearing Device (P090018/S037)Envoy Medical Corporation2018-07-31
Esteem (P090018/S036)Envoy Medical Corporation2017-06-09
Esteem (P090018/S034)Envoy Medical Corporation2017-05-24
Model 7010 Sensor and Model 7510 Driver transducers (P090018/S035)Envoy Medical Corporation2017-04-14
ESTEEM (P090018/S033)Envoy Medical Corporation2017-01-26