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510(k) K980291

IMPOWER EXTERNAL VACUUM SYSTEM by Imagyn Medical Technologies, Inc. — Product Code LKY

K980291 is an FDA 510(k) premarket notification submitted by Imagyn Medical Technologies, Inc. for the device "IMPOWER EXTERNAL VACUUM SYSTEM". The FDA issued a decision of Substantially Equivalent on March 11, 1998. The device falls under product code LKY (Device, External Penile Rigidity), a Class II device regulated under 21 CFR 876.5020. Imagyn Medical Technologies, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1998
Date Received
January 26, 1998
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 Imagyn Medical Technologies, Inc.

  • K032491 — ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR (September 4, 2003)
  • K012706 — IM2001 PULSE OXIMETER (March 7, 2003)
  • K010166 — IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM (December 3, 2001)
  • K991526 — ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501 (June 17, 1999)
  • K980096 — OAC (OPTICAL ASPIRATING CURETTE) (May 1, 1998)
  • K974173 — ERECAID SYSTEM/STAY EREC SYSTEM (February 25, 1998)

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