Atlas FDA

Electrosurgical accessory

FDA 510(k) clearance K210394 · decided 2021-05-19

Clearance details

K-number
K210394
Device name
Electrosurgical accessory
Applicant
Dornier Medtech America, Inc.
Decision
Substantially Equivalent
Date received
2021-02-10
Decision date
2021-05-19
Days to decision
98 days
Clearance type
Traditional
Product code
FAS
Device class
2
Regulation number
876.4300
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Kennesaw, GA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
DORNIER EPOS ULTRA (P000048)Dornier Medtech America, Inc.2002-01-15
DORNIER COMPACT DELTA LITHOTRIPTER-STATIONARY, MOBILE AND TRANSPORTABLE/FS2000 X-RAY MODULE (P840008/S069)Dornier Medtech America, Inc.1999-09-02
DORNIER LITHOTRIPTER-DOLI S AND COMPACT DELTA (P840008/S067)Dornier Medtech America, Inc.1999-03-12
UROWAVE (P970044/S003)Dornier Medtech America, Inc.1999-03-12
DORNIER COMPACT DELTA LITHOTRIPTER-STATIONARY, MOBILE/TRANSPORTABLE (P840008/S068)Dornier Medtech America, Inc.1999-02-26
DORNIER COMPACT DELTA LITHOTRIPTER (P840008/S066)Dornier Medtech America, Inc.1998-08-21
DORNIER UROWAVE MICROWAVE THERMOTHERAPY SYSTEM (P970044/S002)Dornier Medtech America, Inc.1998-07-10
DORNIER COMPACT DELTA (P840008/S065)Dornier Medtech America, Inc.1998-07-07