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510(k) K013113

MODIFICATION TO NANMA VACUUM PUMP by Nanma Mfg Co., Ltd. — Product Code LKY

K013113 is an FDA 510(k) premarket notification submitted by Nanma Mfg Co., Ltd. for the device "MODIFICATION TO NANMA VACUUM PUMP". The FDA issued a decision of Substantially Equivalent on December 20, 2002. The device falls under product code LKY (Device, External Penile Rigidity), a Class II device regulated under 21 CFR 876.5020. Nanma Mfg Co., Ltd. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2002
Date Received
September 18, 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 Nanma Mfg Co., Ltd.

  • K041573 — NANMA VACUUM PUMP PROXZEK MODEL 2M9498S (August 25, 2004)
  • K030119 — NANMA ADJUSTABLE CONSTRICTION RING (August 6, 2003)
  • K030913 — NANMA VACUUM PUMP (June 3, 2003)
  • K013051 — NANMA ADJUSTABLE CONSTRICTION RING (August 22, 2002)
  • K013053 — MODIFICATION TO NANMA NON-ADJUSTABLE CONSTRICTION RING (May 9, 2002)
  • K993909 — NANMA VACUUM PUMP (July 19, 2000)
  • K993906 — NANMA NON-ADJUSTABLE CONSTRICTION RING (January 31, 2000)
  • K993908 — NANMA AJUSTABLE CONSTRICTION RING (January 31, 2000)

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)
  • 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)
  • K020082 — ERECAID CLASSIC SYSTEM; ERECAID ESTEEM MANUAL SYSTEM; ERECAID ESTEEM BATTERY SYS (February 5, 2002)

FDA data resources