Curon Medical, Inc.

Sunnyvale, CA, US

Curon Medical, Inc. appears in FDA device records in Sunnyvale, CA. FDA records list 5 510(k) clearances between 2000-10-17 and 2015-09-23, no PMA records and no registered establishments. As of 2026-09-10, FDA records show 2 recalls for this company.

510(k) clearances: 5
PMA records: 0
Recall records: 2
Registered establishments: 0

FDA records under these names

1 name

FDA records resolved to Curon Medical, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Mederi Therapeutics, Inc.510(k), enforcement report, recall

510(k) clearance history

FDA records hold 5 510(k) clearances for Curon Medical, Inc. between 2000 and 2015. The busiest year on record is 2000, with 1. The most recent is 2015, with 1.

Clearances by year, as a table

510(k) clearance decisions for Curon Medical, Inc., by decision year
Year	Clearances
2000	1
2001	1
2002	1
2011	1
2015	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K152317	Stretta Catheter	GEI	Substantially Equivalent	2015-09-23
K103017	MEDERI THERAPEUTICS RF GENERATOR CONTROL MODULE	GEI	Substantially Equivalent	2011-01-20
K014216	SECCA SYSTEM	GEI	Substantially Equivalent	2002-03-21
K010210	CONTROL MODULE ALGORITHM ENHANCEMENT FOR THE MODEL S500-ST AND MODEL S400	GEI	Substantially Equivalent	2001-02-21
K002898	CURON CONTROL MODULE ELECTROSURGICAL GENERATOR AND ACCESSORIES, MODEL S500-ST	GEI	Substantially Equivalent	2000-10-17

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

GEIElectrosurgical, Cutting & Coagulation & Accessories

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-2050-2017	Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the MEDERI MDRF1 GENERATOR ONLY. Used in the treatment of gastroesophageal reflux disease (GERD). REF 175-5580	Product sterility compromised due to breach in sterile barrier package	Class II	2017-04-03	Terminated
Z-0663-03	Stretta brand Catheter and Accessory Kit, Part # 175-2575. Model 4301K	Catheter shaft has potential to crack during use.		2003-02-21	Terminated

Verification record

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