PRE-FILLED SYRINGE FOR KOALA IUP
FDA 510(k) clearance K973746 · decided 1997-11-24
Clearance details
- K-number
- K973746
- Device name
- PRE-FILLED SYRINGE FOR KOALA IUP
- Applicant
- Clinical Innovations, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-10-01
- Decision date
- 1997-11-24
- Days to decision
- 54 days
- Clearance type
- Traditional
- Product code
- HFN
- Device class
- 2
- Regulation number
- 884.2700
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Murray, UT, 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 |
|---|---|---|
| Koala Intrauterine Pressure Catheter (IPC-5000E) (K250897) | Clinical Innovations, LLC | 2025-05-22 |
| KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETER (K974389) | Clinical Innovations, Inc. | 1998-02-19 |
| INTRAN 500 (K961424) | Utah Medical Products, Inc. | 1996-07-10 |
| STORC INTRAUTERINE PRESSURE CATHETER (K954955) | Clinical Innovations, Inc. | 1996-04-17 |
| INTRAN PLUS (K955443) | Utah Medical Products, Inc. | 1996-02-20 |
| DISPOSABLE INTRAUTERINE PRESSURE TRANSDUCER (K920375) | Telos Medical Corp. | 1992-10-27 |
| ULTRANS DISPOSABLE INTRAUTERINE (K882224) | Telos Medical Corp. | 1989-10-12 |
| SOFSENS(TM) MODEL LMP-100 INTRAUTERINE PRES. TRANS (K893503) | Laurel Medical Corp. | 1989-06-12 |
Recalls involving this device
No recalls on record reference this clearance.