COLONIC BALLOON DILATOR
FDA 510(k) clearance K901426 · decided 1990-06-21
Clearance details
- K-number
- K901426
- Device name
- COLONIC BALLOON DILATOR
- Applicant
- Telemed Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-03-26
- Decision date
- 1990-06-21
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- FFP
- Device class
- 1
- Regulation number
- 876.5450
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Hudson, MA, 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 |
|---|---|---|
| ANOKRYO (K964634) | Mk Conquest Intl., Inc. | 1997-06-06 |
| INAMED RHEMO-D (TM) DILATOR (K894618) | Inamed Development Co. | 1990-01-18 |
| COLONIC BALLOON DIALATORS (K884713) | Primrose Medical, Inc. | 1989-09-29 |
| COLORECTAL DILATOR (K830354) | Cleveland Medical Supply & Services | 1983-05-27 |
Recalls involving this device
No recalls on record reference this clearance.