CATHETER, DISP., EXTERNAL, MALE— 510(k) K772144
Substantially EquivalentMedline Industries, Inc.
FDA 510(k) clearance K772144 for CATHETER, DISP., EXTERNAL, MALE, Substantially Equivalent on 1977-11-28. Applicant: Medline Industries, Inc.. Device class: 1.
Clearance details
- Applicant
- Medline Industries, Inc.
- Product code
- Code EXJ
- Device class
- Class 1
- Regulation
- 21 CFR 876.5250
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code EXJ
view allMore clearances from Medline Industries, Inc.
view all- DEN210049 — Medline ART Skin Harvesting System
- K230559 — Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260)
- K223100 — Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)
- K222665 — Medline UNITE® Ankle Fusion Plating System
- K213054 — Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe
Data sourced from openFDA. This site is unofficial and independent of the FDA.