Bioderm Eid Male External Incontinence Device
FDA 510(k) K963950 · Bioderm, Inc.
510(k) numberK963950
Submission
- Device name
- Bioderm Eid Male External Incontinence Device
- Applicant
- Bioderm, Inc.
East Burnswick, NJ, US - Received
- October 2, 1996
- Decision date
- January 10, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EXI – Device, Paste-On For Incontinence, Sterile
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.5250
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code EXI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K971499 | Female External Urinary Collection PouchEXI · Traditional | Mediquest, Inc. | 08/28/1997SE |
| K970443 | Hollister Retracted Penis PouchEXI · Traditional | Hollister, Inc. | 02/25/1997SE |
| K931277 | Hollister Premium Urine CollectorEXI · Traditional | Hollister, Inc. | 06/23/1993SE |
| K924755 | Convatec Little Ones Pediatric Urine CollectionEXI · Traditional | Convatec, A Division of E.R. Squibb & Sons | 06/22/1993SE |
| K915246 | Conveen(R) Urisheath and Uriliner(Male Exter Cath)EXI · Traditional | Coloplast A/S | 02/05/1992SE |
| K915616 | Urihesive StripEXI · Traditional | Convatec, A Division of E.R. Squibb & Sons | 01/23/1992SE |
More from Convatec, A Division of E.R. Squibb & Sons
| 510(k) | Device | Decision |
|---|---|---|
| K990955 | Modification Of:Bioderm Foam Wound DressingKMF · Traditional | 05/18/1999SE |
| K982778 | Bioderm Foam Wound DressingKMF · Traditional | 10/21/1998SE |
| K982939 | BTF Thin Film Wound DressingMGP · Traditional | 10/13/1998SE |
| K980451 | Bioderm Calcium Alginate DressingKMF · Traditional | 04/09/1998SN |
| K973429 | Bioderm Foam Wound DressingKMF · Traditional | 12/01/1997SN |
| K963602 | Bioderm PVP Foam Wound DressingKMF · Traditional | 10/30/1996SE |
| K951166 | Bioderm Medical Hydrogel Island DressingNAE · Traditional | 06/21/1995SE |
| K951842 | Bioderm Medical Transparent Film DressingMGP · Traditional | 06/12/1995SE |
| K950685 | Bioderm Medical Hydrocolloid Wound DressingKMF · Traditional | 06/09/1995SE |
| K950619 | Bioderm Medical Foam Wound DressingKMF · Traditional | 04/25/1995SE |
Questions and answers
When was Bioderm Eid Male External Incontinence Device cleared by the FDA?
Bioderm Eid Male External Incontinence Device (K963950) received a 510(k) decision of Substantially Equivalent on January 10, 1997, 100 days after the submission was received.
What is the product code of K963950?
The FDA product code is EXI – Device, Paste-On For Incontinence, Sterile, a Class I (low risk) device regulated under 21 CFR 876.5250.