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510(k) K760048

TRAY, URETHRAL CATHETERIZATION by M-C Ind., Inc. — Product Code FCM

K760048 is an FDA 510(k) premarket notification submitted by M-C Ind., Inc. for the device "TRAY, URETHRAL CATHETERIZATION". The FDA issued a decision of Substantially Equivalent on March 1, 1977. The device falls under product code FCM (Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)), a Class II device regulated under 21 CFR 876.5130. M-C Ind., Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1977
Date Received
June 15, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by M-C Ind., Inc.

  • K760047 — TRAY, BLADDER IRRIGATION (March 1, 1977)
  • K760051 — TRAY, SUTURE REMOVAL (August 30, 1976)
  • K760052 — KIT, PREP SHAVE (July 16, 1976)

Other clearances for product code FCM

  • K254076 — BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit (May 29, 2026)
  • K250891 — Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Cathete (June 6, 2025)
  • K223821 — Self-Cath Closed System (August 2, 2023)
  • K082831 — AMSELF CLOSED CATHETERIZATION SYSTEM (October 23, 2008)
  • K070939 — SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM (June 1, 2007)
  • K070048 — GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT (March 15, 2007)
  • K030712 — AMSURE URETHRAL CATHETERIZATION TRAY (May 23, 2003)
  • K030664 — AMSURE FOLEY INSERTION TRAY (May 23, 2003)
  • K011055 — THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS (June 6, 2001)
  • K010420 — RUSCH MMG/O'NEIL CATHETER (May 9, 2001)

FDA data resources