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510(k) K012670

BOSS 2000-3 VACUUM ERECTION DEVICE by Pos-T-Vac, Inc. — Product Code LKY

K012670 is an FDA 510(k) premarket notification submitted by Pos-T-Vac, Inc. for the device "BOSS 2000-3 VACUUM ERECTION DEVICE". The FDA issued a decision of Substantially Equivalent on November 9, 2001. The device falls under product code LKY (Device, External Penile Rigidity), a Class II device regulated under 21 CFR 876.5020. Pos-T-Vac, Inc. has at least 10 other 510(k) clearances on record.

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.

  • K020258 — SUPPORT SLEEVE (April 4, 2002)
  • K020154 — VT-1 (April 4, 2002)
  • K012672 — BOSS-2000-2 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)
  • K020154 — VT-1 (April 4, 2002)
  • K020258 — SUPPORT SLEEVE (April 4, 2002)

FDA data resources