TRI-MED QUICK-STEP(TM) RECTAL TUBE
FDA 510(k) clearance K924549 · decided 1994-02-10
Clearance details
- K-number
- K924549
- Device name
- TRI-MED QUICK-STEP(TM) RECTAL TUBE
- Applicant
- Tri-Med Specialties, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-09-09
- Decision date
- 1994-02-10
- Days to decision
- 519 days
- Clearance type
- Traditional
- Product code
- GBT
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Overland Park, KS, 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 |
|---|---|---|
| INFLATABLE RETENTION CUFF SPECULUM (K941391) | Innovatec Medical Corp. | 1994-10-20 |
| SIGMOID TONOMITOR (K890466) | Tonometrics, Inc. | 1989-04-21 |
Recalls involving this device
No recalls on record reference this clearance.