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510(k) K790271

TRAY AND BAG, CATHETERIZATION by Snyder Laboratories, Inc. — Product Code FCM

K790271 is an FDA 510(k) premarket notification submitted by Snyder Laboratories, Inc. for the device "TRAY AND BAG, CATHETERIZATION". The FDA issued a decision of Substantially Equivalent on March 6, 1979. 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. Snyder Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1979
Date Received
January 9, 1979
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 Snyder Laboratories, Inc.

  • K843906 — SNYDER HEMOVAC WOUND DRAINAGE DEVICES (November 5, 1984)
  • K821321 — SNYDER DEBRIBEMENT SYSTEM LDP-1 (August 6, 1982)
  • K800861 — SNYDER HEMOVAC CHEST DRAINAGE SOLUTION (May 2, 1980)
  • K800578 — SURGIVAC TM (April 16, 1980)
  • K800543 — SNYDER HYSTERECTOMY Y TUBE KIT (April 16, 1980)
  • K800577 — SNYDER HEMOVAC TM VENTED WOUND KIT (April 16, 1980)
  • K800542 — 100 ML SNYDER HEMOVAC (April 2, 1980)
  • K790607 — GREENLINE IRRIGATION TRAYS (May 11, 1979)
  • K790606 — CATHETERS, GREENLINE SUCTION (April 23, 1979)
  • K790419 — YANKAUER & POODLE SUCTION INSTRUMENTS (April 23, 1979)

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