Home / 510(k) Clearances / K020082

510(k) K020082

ERECAID CLASSIC SYSTEM; ERECAID ESTEEM MANUAL SYSTEM; ERECAID ESTEEM BATTERY SYSTEM by Endocare, Inc. — Product Code LKY

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 5, 2002
Date Received: January 10, 2002
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Device, External Penile Rigidity
Device Class: Class II
Regulation Number: 876.5020
Review Panel: GU
Submission Type

Intended to create or maintain sufficient penile rigidity for sexual intercourse. These include vacuum pumps, constriction rings, and penile splints, which are mechanical, powered or pneumatic devices.

Other clearances by Endocare, Inc.

K101333 — CRYOCARE CS SURGICAL SYSTEM (June 14, 2010)
K062175 — CRYOCARE CN2 SYSTEM (August 28, 2006)
K060279 — CRYOCARE CS SURGICAL SYSTEM (February 28, 2006)
K050347 — MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM (February 25, 2005)
K032333 — CRYOCARE CS SURGICAL SYSTEM (August 12, 2003)
K023757 — CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20 (December 5, 2002)
K021010 — MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE (June 6, 2002)
K011074 — CRYOCARE SURGICAL SYSTEM (January 25, 2002)
K003811 — CRYOCARE SURGICAL SYSTEM (October 11, 2001)
K011040 — CRYOCARE CARDIAC SURGICAL SYSTEM (June 15, 2001)

Other clearances for product code LKY

K041573 — NANMA VACUUM PUMP PROXZEK MODEL 2M9498S (August 25, 2004)
K032776 — VACURECT VACUUM CONSTRICTION DEVICE (October 3, 2003)
K030119 — NANMA ADJUSTABLE CONSTRICTION RING (August 6, 2003)
K030913 — NANMA VACUUM PUMP (June 3, 2003)
K013113 — MODIFICATION TO NANMA VACUUM PUMP (December 20, 2002)
K013051 — NANMA ADJUSTABLE CONSTRICTION RING (August 22, 2002)
K020969 — VACURECT VACUUM CONSTRICTION DEVICE (June 5, 2002)
K013053 — MODIFICATION TO NANMA NON-ADJUSTABLE CONSTRICTION RING (May 9, 2002)
K020258 — SUPPORT SLEEVE (April 4, 2002)
K020154 — VT-1 (April 4, 2002)