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510(k) K912146

URETERAL CATHETER HOLDER by Inman Liebelt Corp. — Product Code KNY

K912146 is an FDA 510(k) premarket notification submitted by Inman Liebelt Corp. for the device "URETERAL CATHETER HOLDER". The FDA issued a decision of Substantially Equivalent on July 26, 1991. The device falls under product code KNY (Accessories, Catheter, G-U), a Class II device regulated under 21 CFR 876.5130. Inman Liebelt Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 1991
Date Received
May 15, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Catheter, G-U
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Inman Liebelt Corp.

  • K912211 — INTRAVASCULAR CATHETER SECURMENT DEVICE (August 9, 1991)
  • K905590 — UCEZ - STERILE LENS FOG REDUCTION DEVICE (May 10, 1991)
  • K905583 — ILC FORCEPS PADS (April 12, 1991)
  • K903611 — ILC LEG BAG HOLDER (October 26, 1990)
  • K903610 — O.R. TIP CLEANER (October 19, 1990)

Other clearances for product code KNY

  • K260919 — Transurethral Catheter Safety Valve (TUCSV) (80050) (August 5, 2026)
  • K182144 — Bi-Flex Evo (September 7, 2018)
  • K162356 — Vesair Cystoscopic Sheath (March 2, 2017)
  • K140441 — BI-FLEX URETERAL ACCESS SHEATH (June 17, 2014)
  • K140562 — WIJAY EZ-VOID EXTERNAL CATHETER VALVE (June 16, 2014)
  • K141252 — GUARDIAN URETHRAL SHEATH (June 9, 2014)
  • K131803 — GUARDIAN URETHRAL SHEATH (August 20, 2013)
  • K123170 — VARI-PASS VARIABLE LENGTH ACCESS SHEATH (February 4, 2013)
  • K120160 — ROCAMED ROCAUS PLATINUM (May 14, 2012)
  • K112209 — PREFILLED CATHETER INFLATION SYRINGE (September 8, 2011)

FDA data resources