510(k) K121833
- Device
- OSTOMY IRRIGATION SET
- Applicant
- COLOPLAST A/S
- 510(k) number
- K121833
- Product code
- EXD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-07-16
- Date received
- 2012-06-22
- Regulation
- 876.5895
- Classification name
- Irrigator, Ostomy
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- TIM CRABTREE
- Address
- 1601 W. River Rd. N. Plymouth MN US 55411 55411
FDA Registration Numbers#
- 9618003
- 3013557562
- 2320961
- 3008502431
- 1119193
- 3018507299
- 3016426850
- 3011987967
- 3012502601
- 1048735
- 3008806809
- 2528981
- 9610694
- 3016615875
- 3031233007
- 3003814961
- 1820334
- 3007417132
- 1480288
- 3008191244
- 3030087693
- 1520020
- 1526012
- 3014195785
Source Documents#
Other 510(k) Records For Product Code EXD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K914692 | URINARY DIVERSION EVACUATING CATHETER | Cook Urological, Inc. | 1992-07-02 |
| K904586 | PALEX IRRIGATION SET | Palex Intl. SA | 1990-12-28 |
| K871791 | BLOXOM IRRIGATOR | I.B. Bloxom C/O Hogan & Hartson | 1987-05-20 |
| K840268 | IRRIGATION SYSTEM | Coloplast A/S | 1984-04-05 |
| K832299 | VISI-FLOW IRRIGATOR | Convatec, A Division of E.R. Squibb & Sons | 1983-08-26 |
| K823274 | UNI-TIP COLOSTOMY IRRIGATION CONE | Howmedica Corp. | 1982-12-07 |
| K811160 | SUR-FIT IRRIGATION SLEEVE | E. R. Squibb & Sons, Inc. | 1981-06-02 |
| K790749 | COLOSTOMY ENEMA DEVICE | Vabar Corp. | 1979-05-16 |
| K790750 | COLOSTOMY DEVICE W/ PRESSURE LID | Vabar Corp. | 1979-05-14 |
| K760810 | TUBE, GASTRO-ENTEROSTOMY | Sherwood Medical Industries | 1977-02-28 |
| K770251 | SUPER X ADJUSTRETTE | Qualitone | 1977-02-28 |
Legacy Summary#
summary
FDA Review#
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