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510(k) K022614

INVIGRA by Indus Medicare , Ltd. — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2003
Date Received
August 6, 2002
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Condom
Device Class
Class II
Regulation Number
884.5300
Review Panel
OB
Submission Type

Other clearances by Indus Medicare , Ltd.

  • K020223 — INVIGRA (March 4, 2002)
  • K000039 — INVIGRA MALE LATEX CONDOM YELLOW COLORED AND BANANA FLAVORED (March 21, 2000)
  • K000040 — INVIGRA MALE LATEX CONDOM BLUE COLORED AND VANILLA FLAVORED (March 21, 2000)
  • K000038 — INVIGRA MALE LATEX CONDOM GREEN COLORED AND MINT FLAVORED (March 21, 2000)
  • K993693 — INVIGRA (December 29, 1999)
  • K992438 — INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT) (August 2, 1999)
  • K991374 — INVIGRA (June 15, 1999)

Other clearances for product code HIS

  • K252521 — LifeStyles® HydraFeel Natural Rubber Latex Condom (November 18, 2025)
  • K250034 — Natural rubber latex male condom (July 11, 2025)
  • K243421 — Lelo Hex Lubricated Natural Rubber Latex Condom (March 7, 2025)
  • K243640 — Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed E (February 21, 2025)
  • K243584 — 0.04 ZERO ZERO FOUR Male Latex Condom (February 18, 2025)
  • K232279 — LifeStyles NRL Textured Condom (October 5, 2023)
  • K230049 — SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE (September 7, 2023)
  • K222611 — Male Latex Condoms (November 28, 2022)
  • K220489 — Durex Patronus CloseFit, Durex Patronus Regular (November 7, 2022)
  • K222068 — Durex Penck III Regular (October 12, 2022)