Urinary Drainage Bag
FDA 510(k) K934080 · Kit Pak, Inc.
510(k) numberK934080
Submission
- Device name
- Urinary Drainage Bag
- Applicant
- Kit Pak, Inc.
Elk Grove Village, IL, US - Received
- August 20, 1993
- Decision date
- May 18, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- EYT – Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.5250
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code EYT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K935774 | Curity Fast-Cath Female Catheter KitEYT · Traditional | Kendall Healthcare Products Co. Div.Of Tyco Health | 04/11/1994SEKD |
| K883119 | Vpi Non-Adhesive Condom CatheterEYT · Traditional | Cook Urological, Inc. | 08/02/1988SE |
| K883057 | Comfort Cath Male External CatheterEYT · Traditional | Sierra Laboratories, Inc. | 08/02/1988SE |
More from Sierra Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K942959 | Kit Pak Wet Saline DressingFRO · Traditional | 02/14/1995SN |
| K941499 | Kit Pak Dressing Change TrayKGX · Traditional | 07/20/1994SEKD |
| K932310 | Kit Pak Incontinent Skin Care KitEYQ · Traditional | 06/01/1994SEKD |
| K931013 | Foley Catheter TrayKNY · Traditional | 08/09/1993SE |
| K923905 | Wound Dressing KitMCY · Traditional | 07/02/1993SEKD |
| K924051 | Kit Pak I.V. Start KitLYY · Traditional | 06/22/1993SEKD |
| K923906 | Foley Insertion TrayKOD · Traditional | 06/22/1993SEKD |
| K922051 | Kit Pak's Flushing KitKOD · Traditional | 06/17/1993SESK |
| K925281 | Kit Pak Urinary Care SuppliesKNY · Traditional | 04/19/1993SESK |
| K900148 | Kit Pak Irrigation TrayEYN · Traditional | 04/23/1990SEKD |
Questions and answers
When was Urinary Drainage Bag cleared by the FDA?
Urinary Drainage Bag (K934080) received a 510(k) decision of Substantially Equivalent on May 18, 1994, 271 days after the submission was received.
What is the product code of K934080?
The FDA product code is EYT – Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile, a Class I (low risk) device regulated under 21 CFR 876.5250.