Home / 510(k) Clearances / K923591

510(k) K923591

PALA-NATE by Gesco Intl., Inc. — Product Code BTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1993
Date Received
July 20, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tracheal (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5730
Review Panel
AN
Submission Type

Other clearances by Gesco Intl., Inc.

  • K954422 — PER-Q-CATH MID-LINE (December 15, 1995)
  • K940870 — UMBILI-CATH (August 2, 1994)
  • K940953 — UMBILI-CATH-S (August 2, 1994)
  • K940952 — UMBILI-CATH-S-DL (July 29, 1994)
  • K941672 — URI-CATH CATHETER (May 16, 1994)
  • K941232 — THORA-CATH (May 11, 1994)
  • K940871 — UMBILI-CATH-P (April 29, 1994)
  • K931989 — VENTRI-CATH (July 21, 1993)
  • K926063 — PER-Q-CATH DRESSING CHANGE TRAY (June 7, 1993)
  • K915167 — GESCO PER-Q-CATH CATHETER INTRODUCER (January 27, 1992)

Other clearances for product code BTR

  • K250173 — Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE T (October 6, 2025)
  • K243785 — Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye S (September 25, 2025)
  • K243579 — AeroJet Ventilation Catheter (August 13, 2025)
  • K251499 — Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C- (June 11, 2025)
  • K250243 — ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); (May 20, 2025)
  • K242495 — LMA Fastrach ETT SU (April 29, 2025)
  • K241451 — Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); (February 11, 2025)
  • K233341 — Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, (May 20, 2024)
  • K223130 — Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP ( (August 30, 2023)
  • K211543 — Wei Nasal Jet Tube (July 21, 2022)