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510(k) K003115

ACTIS ADJUSTABLE CONSTRICTION LOOP by Vivus, Inc. — Product Code LKY

K003115 is an FDA 510(k) premarket notification submitted by Vivus, Inc. for the device "ACTIS ADJUSTABLE CONSTRICTION LOOP". The FDA issued a decision of Substantially Equivalent on December 19, 2000. The device falls under product code LKY (Device, External Penile Rigidity), a Class II device regulated under 21 CFR 876.5020. Vivus, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2000
Date Received
October 2, 2000
Clearance Type
Traditional
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 Vivus, Inc.

  • K962915 — ACTIS (VENOUS FLOW CONTROLLER) (December 10, 1996)

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