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510(k) K192691

PatCom Single-Use Introducer by H&A Mui Enterprises, Inc. — Product Code FED

K192691 is an FDA 510(k) premarket notification submitted by H&A Mui Enterprises, Inc. for the device "PatCom Single-Use Introducer". The FDA issued a decision of Substantially Equivalent on February 21, 2020. The device falls under product code FED (Endoscopic Access Overtube, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. H&A Mui Enterprises, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2020
Date Received
September 26, 2019
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

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

Other clearances by H&A Mui Enterprises, Inc.

  • K222587 — PatCom Distal Chip Endoscope (July 28, 2023)

Other clearances for product code FED

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

FDA data resources