510(k) K012672

BOSS-2000-2 VACUUM ERECTION DEVICE by Pos-T-Vac, Inc. — Product Code LKY

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 9, 2001
Date Received: August 13, 2001
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 Pos-T-Vac, Inc.

K020154 — VT-1 (April 4, 2002)
K020258 — SUPPORT SLEEVE (April 4, 2002)
K012670 — BOSS 2000-3 VACUUM ERECTION DEVICE (November 9, 2001)
K983246 — POS-T-VAC (IVP-600) (November 2, 1998)
K983245 — POS-T-VAC (AVP-1000) (November 2, 1998)
K981180 — REJOYN CONSTRICTION RING KIT, POS-T-VAC B-100 RING KIT, POS-T-VAC B-25 RING KIT (August 28, 1998)
K981011 — POS-T-VAC (REJOYN VACUUM ERECTION DEVICE) (August 28, 1998)
K961309 — POS-T-VAC ID-300 (June 10, 1996)
K960828 — POS-T-VAC B-10 BAND KIT (March 8, 1996)
K960342 — POS-T-VAC AVP-1000 & MVP-700 (March 1, 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)
K020258 — SUPPORT SLEEVE (April 4, 2002)
K020154 — VT-1 (April 4, 2002)