Welcon Light Handle
FDA 510(k) K894397 · Welcon, Inc.
510(k) numberK894397
Submission
- Device name
- Welcon Light Handle
- Applicant
- Welcon, Inc.
Providence, RI, US - Received
- July 20, 1989
- Decision date
- August 10, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FTA – Light, Surgical, Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4580
- Specialty
- General, Plastic Surgery
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| 510(k) | Device | Decision |
|---|---|---|
| K003402 | Welcon Sterile Water for Device Irrigation; Welcon Sterile 0.9% Normal Saline for Device…JOL · Traditional | 05/01/2001SE |
| K973734 | Sterile Water for Device Irrigation/ Sterile Saline for Device IrrigationJOL · Traditional | 02/05/1998SE |
| K971764 | Welcon Hue-Vu Urinary Drainage BagKNX · Traditional | 07/29/1997SE |
| K912869 | Women and Infant's Delivery PackHFW · Traditional | 12/04/1991SE |
| K904158 | Accorde(R) Irrigating Syringe/Procedure TrayFCM · Traditional | 11/29/1990SEKD |
| K830359 | Sterile Catherization Procedure TraysKOD · Traditional | 03/17/1983SE |
| K813027 | Sterile Irrigating Syringes, Kits,TrayKYZ · Traditional | 11/20/1981SE |
Questions and answers
When was Welcon Light Handle cleared by the FDA?
Welcon Light Handle (K894397) received a 510(k) decision of Substantially Equivalent on August 10, 1989, 21 days after the submission was received.
What is the product code of K894397?
The FDA product code is FTA – Light, Surgical, Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4580.