INFLATABLE RETENTION CUFF SPECULUM
FDA 510(k) clearance K941391 · decided 1994-10-20
Clearance details
- K-number
- K941391
- Device name
- INFLATABLE RETENTION CUFF SPECULUM
- Applicant
- Innovatec Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1994-03-22
- Decision date
- 1994-10-20
- Days to decision
- 212 days
- Clearance type
- Traditional
- Product code
- GBT
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Duluth, GA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Innovatec Medical Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TRI-MED QUICK-STEP(TM) RECTAL TUBE (K924549) | Tri-Med Specialties, Inc. | 1994-02-10 |
| SIGMOID TONOMITOR (K890466) | Tonometrics, Inc. | 1989-04-21 |
Recalls involving this device
No recalls on record reference this clearance.