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510(k) K924549

TRI-MED QUICK-STEP(TM) RECTAL TUBE by Tri-Med Specialties, Inc. — Product Code GBT

K924549 is an FDA 510(k) premarket notification submitted by Tri-Med Specialties, Inc. for the device "TRI-MED QUICK-STEP(TM) RECTAL TUBE". The FDA issued a decision of Substantially Equivalent on February 10, 1994. The device falls under product code GBT (Catheter, Rectal), a Class II device regulated under 21 CFR 876.5980. Tri-Med Specialties, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1994
Date Received
September 9, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Rectal
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

Other clearances by Tri-Med Specialties, Inc.

  • K971615 — PATTISON ESOPHAGEAL DILATOR (July 24, 1997)
  • K970890 — #ES-32 SUCTION CATHETER 32 FR. (May 23, 1997)
  • K970982 — T-RX RETRIEVAL FORCEPS (May 9, 1997)
  • K942918 — TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER (February 28, 1995)
  • K950574 — NEEDLE/CANNULA (February 24, 1995)
  • K934348 — TRI-MED QUICK-STEP GASTRIC LAVAGE TUBE SIZES 18FR, 22FR, 32FR (December 23, 1994)
  • K945160 — PARACENTESIS NEEDLES/CANNULAS (November 14, 1994)
  • K932015 — TRI-MED INFLATABLE ESOPHAGEAL DILATOR (February 3, 1994)
  • K932652 — TRI-MED PARACENTESIS TRAY (November 24, 1993)
  • K931201 — TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER (September 28, 1993)

Other clearances for product code GBT

  • K941391 — INFLATABLE RETENTION CUFF SPECULUM (October 20, 1994)
  • K890466 — SIGMOID TONOMITOR (April 21, 1989)

FDA data resources