UC-2000 UTERINE CATHERIZATION SYSTEM
FDA 510(k) clearance K791633 · decided 1979-09-17
Clearance details
- K-number
- K791633
- Device name
- UC-2000 UTERINE CATHERIZATION SYSTEM
- Applicant
- Life Support, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-08-21
- Decision date
- 1979-09-17
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- HFO
- Device class
- 2
- Regulation number
- 884.2700
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Mchenry, IL, 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 |
|---|---|---|
| ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M007 (K973850) | Alexander Mfg. Co. | 1997-11-12 |
| LAPAROSCOPIC/ENDOSCOPIC INSTRUEMENT (K943989) | Gabris Surgical Corp. | 1994-09-12 |
| FETAL MONITORING SYSTEM (K780487) | Sonicaid, Inc. | 1978-05-09 |
Recalls involving this device
No recalls on record reference this clearance.