Atlas FDA

Tasso+

FDA 510(k) clearance K221131 · decided 2022-08-12

Clearance details

K-number
K221131
Device name
Tasso+
Applicant
Tasso, Inc.
Decision
Substantially Equivalent
Date received
2022-04-18
Decision date
2022-08-12
Days to decision
116 days
Clearance type
Traditional
Product code
FMK
Device class
2
Regulation number
878.4850
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Seattle, WA, US
Third-party review
No
Expedited review
No

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RecordFirmDate
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LetsGetChecked Impress (K242680)Privapath Diagnostics Ltd (Dba Letsgetchecked)2025-01-13
Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus (K243533)Hlb Co., Ltd. Healthcare2025-01-13
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Safety Lancet (K242627)Ningbo Medsun Medical Co., Ltd.2024-10-30
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Recalls involving this device

No recalls on record reference this clearance.