Home / 510(k) Clearances / K200419

510(k) K200419

Kalera Vacuum Aspiration Catheter (K-VAC) by Kalera Medical, Inc. — Product Code FED

K200419 is an FDA 510(k) premarket notification submitted by Kalera Medical, Inc. for the device "Kalera Vacuum Aspiration Catheter (K-VAC)". The FDA issued a decision of Substantially Equivalent on May 22, 2020. The device falls under product code FED (Endoscopic Access Overtube, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2020
Date Received
Feb 20, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Access Overtube, Gastroenterology-Urology
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type
510(k)

To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.

Other clearances for product code FED

  • K262262 — Pathfinder Endoscope Overtube (Sep 18, 2026)
  • K260410 — Single Use Ureteral Access Sheath (Sep 11, 2026)
  • K261915 — Navigator™ Flex Ureteral Access Sheath Set (Aug 4, 2026)
  • K260965 — CVAC Aspiration System (Apr 13, 2026)
  • K260521 — ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050… (Apr 6, 2026)
  • K252572 — Prodeon Urethral Sheath System (Oct 7, 2025)
  • K250128 — Single Use Suction-Evacuation Ureteral Access Sheath (Sep 19, 2025)
  • K250132 — Ureteral Access Sheath (Sep 5, 2025)
  • K250695 — Single-use Ureteral Access Sheath (Jul 8, 2025)
  • K251599 — Single-use Ureteral Access Sheath (Jul 3, 2025)

FDA data resources