BLOXOM IRRIGATOR
FDA 510(k) clearance K871791 · decided 1987-05-20
Clearance details
- K-number
- K871791
- Device name
- BLOXOM IRRIGATOR
- Applicant
- I.B. Bloxom C/O Hogan & Hartson
- Decision
- Substantially Equivalent
- Date received
- 1987-05-07
- Decision date
- 1987-05-20
- Days to decision
- 13 days
- Clearance type
- Traditional
- Product code
- EXD
- Device class
- 2
- Regulation number
- 876.5895
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Washington, D.C., DC, 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 |
|---|---|---|
| OSTOMY IRRIGATION SET (K121833) | Coloplast A/S | 2012-07-16 |
| URINARY DIVERSION EVACUATING CATHETER (K914692) | Cook Urological, Inc. | 1992-07-02 |
| PALEX IRRIGATION SET (K904586) | Palex Intl. SA | 1990-12-28 |
| IRRIGATION SYSTEM (K840268) | Coloplast A/S | 1984-04-05 |
| VISI-FLOW IRRIGATOR (K832299) | Convatec, A Division of E.R. Squibb & Sons | 1983-08-26 |
| UNI-TIP COLOSTOMY IRRIGATION CONE (K823274) | Howmedica Corp. | 1982-12-07 |
| SUR-FIT IRRIGATION SLEEVE (K811160) | E. R. Squibb & Sons, Inc. | 1981-06-02 |
| COLOSTOMY ENEMA DEVICE (K790749) | Vabar Corp. | 1979-05-16 |
| COLOSTOMY DEVICE W/ PRESSURE LID (K790750) | Vabar Corp. | 1979-05-14 |
| TUBE, GASTRO-ENTEROSTOMY (K760810) | Sherwood Medical Industries | 1977-02-28 |
| SUPER X ADJUSTRETTE (K770251) | Qualitone | 1977-02-28 |
Recalls involving this device
No recalls on record reference this clearance.