EXB — Collector, Ostomy Class I
FDA product code EXB covers "Collector, Ostomy", a Class I medical device regulated under 21 CFR 876.5900. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- EXB
- Device Class
- Class I
- Regulation Number
- 876.5900
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252140 | coloplast | Heylo System | October 6, 2025 |
| K181643 | 11 health technologies limited | SmartBag (SmartPouch) | November 16, 2018 |
| K140938 | 11 health and technologies | OSTOM-I ALERT | October 10, 2014 |
| K922730 | lake medical products | LAKE OSTOMY CARE SET | December 30, 1993 |
| K882878 | cdc products | ODOR-END EMERGENCY CLEAN UP POWDER | December 8, 1988 |
| K881636 | coloplast | CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE) | July 13, 1988 |
| K880306 | cdc products | EMERGENCY-CLEAN UP(TM) ECP | May 20, 1988 |
| K872294 | arnold technologies | COMBINATION NITE DRAINAGE UNIT | December 29, 1987 |
| K873929 | midwest medical | 'CATCH-IT' OR FECAL CONTAINMENT DEVICE | December 3, 1987 |
| K871526 | cox family laboratories | ODOR-SAFE(TM)(LIQUID) ODOR-SAFE(TM) POWDER | October 13, 1987 |
| K871738 | clearchem | OSTO-PURE | August 12, 1987 |
| K871628 | industrias palex c/o dma med-chem | PALEX (R) OSTOMY | July 8, 1987 |
| K870577 | john f. greer co | E-Z LOOP | April 17, 1987 |
| K870531 | john f. greer co | EZ TAC FILTER | April 10, 1987 |
| K870136 | arnold technologies | PERSONAL PUNCH | April 1, 1987 |
| K864189 | john f. greer co | ULTRA-GEL - #4083 | December 4, 1986 |
| K862631 | c.r. bard | BARD IRYFIX(TM) STOMA CAP | October 16, 1986 |
| K861070 | coloplast | COLOPLAST CONVEX RING | June 16, 1986 |
| K855019 | convatec, a division of e.r. squibb and sons | DURAHESIVE PROTECTIVE BARRIER WIPE | April 16, 1986 |
| K854726 | pfizer | MEDI-WIPES UNITED ANTISEPTIC SKIN PREP | February 24, 1986 |