← Back to catalogue

Davol X-Stream Laparoscopic Irrigation System (5551000 +6 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K003790

by Davol Inc.

Identifiers

510(k) Number
K003790 FDA 510(k)
FDA Product Code
GCJ FDA 510(k)
Models / Variants
5551000 FDA 510(k)
5552000 FDA 510(k)
5552001 FDA 510(k)
552002 FDA 510(k)
5552003 FDA 510(k)
5552004 FDA 510(k)
5552005 FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1500 FDA 510(k)
Regulation Number
876.1500 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Davol X-Stream Laparoscopic Irrigation System (5551000 +6 more) by Davol Inc. — Class II — FDA_510K — listed in FDA 510(k) — 7 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Davol Inc.
FDA Applicant
Davol, Inc.

Sources (1)

  • FDA 510(k) K003790 24 fields · synced Jun 18, 2026