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510(k) K020082

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

K020082 is an FDA 510(k) premarket notification submitted by Endocare, Inc. for the device "ERECAID CLASSIC SYSTEM; ERECAID ESTEEM MANUAL SYSTEM; ERECAID ESTEEM BATTERY SYSTEM". The FDA issued a decision of Substantially Equivalent on February 5, 2002. The device falls under product code LKY (Device, External Penile Rigidity), a Class II device regulated under 21 CFR 876.5020. Endocare, Inc. has at least 10 other 510(k) clearances on record.

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)
  • K020154 — VT-1 (April 4, 2002)
  • K020258 — SUPPORT SLEEVE (April 4, 2002)

FDA data resources