Siesta Medical, Inc.

Los Gatos, CA, US

SIESTA MEDICAL, INC. appears in FDA device records in Los Gatos, CA. FDA records list 10 510(k) clearances between 2010-07-08 and 2021-12-22, no PMA records and one registered establishment. As of 2026-09-10, FDA records show no recalls for this company, and at least one establishment registration is current.

510(k) clearances: 10
PMA records: 0
Recall records: 0
Registered establishments: 1

510(k) clearance history

FDA records hold 10 510(k) clearances for Siesta Medical, Inc. between 2010 and 2021. The busiest year on record is 2010, with 2. The most recent is 2021, with 1.

Clearances by year, as a table

510(k) clearance decisions for Siesta Medical, Inc., by decision year
Year	Clearances
2010	2
2011	2
2012	2
2014	1
2019	1
2020	1
2021	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K213159	Encore System	ORY	Substantially Equivalent	2021-12-22
K201238	Encore System	ORY	Substantially Equivalent	2020-10-02
K183310	Encore System	ORY	Substantially Equivalent	2019-05-09
K133680	ENCORE SYSTEM	ORY	Substantially Equivalent	2014-03-26
K121440	ENCORE TONGUE SUSPENSION SYSTEM ENCORE REMOVAL-TITRATION KIT	ORY	Substantially Equivalent	2012-12-06
K121814	ENCORE TONGUE SUSPENSION SYSTEM	ORY	Substantially Equivalent	2012-11-07
K111179	ENCORE TONGUE SUSPENSION SYSTEM (MONOFILAMENT #1 SUSPENSION SUTURE), ENCORE TONGUE SUSPENSION SYSTEM SYSTEM (MONOFILAMEN	ORY	Substantially Equivalent	2011-07-01
K110127	PRELUDE III TONGUE SUSPENSION SYSTEM	ORY	Substantially Equivalent	2011-04-08
K103179	PRELUDE II TOUNGE SUSPENSION SYSTEM	ORY	Substantially Equivalent	2010-12-20
K101060	SIESTA MEDICAL, INC., PRELUDE TONGUE SUSPENSION SYSTEM	ORY	Substantially Equivalent	2010-07-08

Registered establishments

FDA registered establishments for Siesta Medical, Inc., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3008792120	3008792120	SIESTA MEDICAL, INC.	101 Church St, Los Gatos, CA 95030 US	2026	HWQ HXC ORY

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain