PALEX (R) OSTOMY
FDA 510(k) clearance K871628 · decided 1987-07-08
Clearance details
- K-number
- K871628
- Device name
- PALEX (R) OSTOMY
- Applicant
- Industrias Palex C/O Dma Med-Chem Corp.
- Decision
- Substantially Equivalent
- Date received
- 1987-04-27
- Decision date
- 1987-07-08
- Days to decision
- 72 days
- Clearance type
- Traditional
- Product code
- EXB
- Device class
- 1
- Regulation number
- 876.5900
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Great Neck, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Heylo™ System (K252140) | Coloplast Corp. | 2025-10-06 |
| SmartBag (SmartPouch) (K181643) | 11 Health Technologies Limited | 2018-11-16 |
| OSTOM-I ALERT (K140938) | 11 Health and Technologies, LLC | 2014-10-10 |
| LAKE OSTOMY CARE SET (K922730) | Lake Medical Products, Inc. | 1993-12-30 |
| ODOR-END EMERGENCY CLEAN UP POWDER (K882878) | Cdc Products Corp. | 1988-12-08 |
| CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE) (K881636) | Coloplast A/S | 1988-07-13 |
| EMERGENCY-CLEAN UP(TM) ECP (K880306) | Cdc Products Corp. | 1988-05-20 |
| COMBINATION NITE DRAINAGE UNIT (K872294) | Arnold Technologies | 1987-12-29 |
| 'CATCH-IT' OR FECAL CONTAINMENT DEVICE (K873929) | Midwest Medical Co. | 1987-12-03 |
| ODOR-SAFE(TM)(LIQUID) ODOR-SAFE(TM) POWDER (K871526) | Cox Family Laboratories, Inc. | 1987-10-13 |
| OSTO-PURE (K871738) | Clearchem Corp. | 1987-08-12 |
| E-Z LOOP (K870577) | John F. Greer Co., Inc. | 1987-04-17 |
Recalls involving this device
No recalls on record reference this clearance.