United Skin Barriers
FDA 510(k) K844938 · Pfizer, Inc.
510(k) numberK844938
Submission
- Device name
- United Skin Barriers
- Applicant
- Pfizer, Inc.
Ny, NY, US - Received
- December 20, 1984
- Decision date
- January 18, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EXB – Collector, Ostomy
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.5900
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code EXB
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|---|---|---|---|
| K252140 | Heylo SystemEXB · Traditional | Coloplast Corp. | 10/06/2025SE |
| K181643 | SmartBag (SmartPouch)EXB · Traditional | 11 Health Technologies Limited | 11/16/2018SE |
| K140938 | Ostom-I AlertEXB · Traditional | 11 Health and Technologies, LLC | 10/10/2014SE |
| K922730 | Lake Ostomy Care SetEXB · Traditional | Lake Medical Products, Inc. | 12/30/1993SESK |
| K882878 | Odor-End Emergency Clean Up PowderEXB · Traditional | Cdc Products Corp. | 12/08/1988SE |
| K881636 | Conseal Colostomy Continence System (One-Piece)EXB · Traditional | Coloplast A/S | 07/13/1988SE |
| K880306 | Emergency-Clean Up(Tm) EcpEXB · Traditional | Cdc Products Corp. | 05/20/1988SE |
| K872294 | Combination Nite Drainage UnitEXB · Traditional | Arnold Technologies | 12/29/1987SE |
| K873929 | 'Catch-It' or Fecal Containment DeviceEXB · Traditional | Midwest Medical Co. | 12/03/1987SE |
| K871526 | Odor-Safe(Tm)(Liquid) Odor-Safe(Tm) PowderEXB · Traditional | Cox Family Laboratories, Inc. | 10/13/1987SE |
More from Cox Family Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K181102 | ThermaCare Quick Therapy TENSNUH · Traditional | 09/15/2018SE |
| K991620 | Visine for ContactsLPN · Traditional | 09/24/1999SE |
| K892264 | Oralchek Super-Soft BrushEFW · Traditional | 06/14/1989SE |
| K892360 | Water Jel Sterile Gel-Soaked Burn DressingFRO · Traditional | 06/05/1989SE |
| K881378 | Pfizer Hospital Products Group Acl Drill GuideLXI · Traditional | 06/17/1988SE |
| K854726 | Medi-Wipes United Antiseptic Skin PrepEXB · Traditional | 02/24/1986SE |
| K850840 | Howmedica Threaded Acetabular ComponentKWA · Traditional | 07/15/1985SE |
| K850443 | Mec Rod ConnectorKTT · Traditional | 07/15/1985SE |
| K850413 | Mec Hip BoltKTT · Traditional | 07/15/1985SE |
| K850403 | Mec Distal Femoral BoltKTT · Traditional | 07/15/1985SE |
Questions and answers
When was United Skin Barriers cleared by the FDA?
United Skin Barriers (K844938) received a 510(k) decision of Substantially Equivalent on January 18, 1985, 29 days after the submission was received.
What is the product code of K844938?
The FDA product code is EXB – Collector, Ostomy, a Class I (low risk) device regulated under 21 CFR 876.5900.