Siesta Medical, Inc.

FDA Regulatory Profile

Siesta Medical, Inc. appears in FDA public data with 0 recalls, 10 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on December 22, 2021.

Summary

Total Recalls
0
510(k) Clearances
10
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K213159Encore SystemDecember 22, 2021
K201238Encore SystemOctober 2, 2020
K183310Encore SystemMay 9, 2019
K133680ENCORE SYSTEMMarch 26, 2014
K121440ENCORE TONGUE SUSPENSION SYSTEM ENCORE REMOVAL-TITRATION KITDecember 6, 2012
K121814ENCORE TONGUE SUSPENSION SYSTEMNovember 7, 2012
K111179ENCORE TONGUE SUSPENSION SYSTEM (MONOFILAMENT #1 SUSPENSION SUTURE), ENCORE TONGUE SUSPENSION SYSTEMJuly 1, 2011
K110127PRELUDE III TONGUE SUSPENSION SYSTEMApril 8, 2011
K103179PRELUDE II TOUNGE SUSPENSION SYSTEMDecember 20, 2010
K101060SIESTA MEDICAL, INC., PRELUDE TONGUE SUSPENSION SYSTEMJuly 8, 2010