Home / 510(k) Clearances / K253537

510(k) K253537

Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter)); Glean Urodynamics System Abdominal Sensor (GUS-1000-A) by Bright Uro, Inc. — Product Code EXQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2026
Date Received
November 13, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cystometer, Electrical Recording
Device Class
Class II
Regulation Number
876.1620
Review Panel
GU
Submission Type

Other clearances by Bright Uro, Inc.

  • K243052 — Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics Sy (March 24, 2025)

Other clearances for product code EXQ

  • K243052 — Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics Sy (March 24, 2025)
  • K931282 — VOLUME TRANSDUCER (September 17, 1993)
  • K931574 — ADVANCE MODEL UDS-ADV (August 5, 1993)
  • K920574 — CAMSYS 6300 (February 17, 1993)
  • K880391 — DACOMED CYSTOMETER (April 27, 1988)
  • K812177 — LIFE-TECH #1857 PRESSURE/POLOT MODULE (September 9, 1981)
  • K781032 — AQUA-GEL (December 15, 1978)