UTERINE SOUND, BURNETT DISPOSABLE
FDA 510(k) clearance K781766 · decided 1978-12-07
Clearance details
- K-number
- K781766
- Device name
- UTERINE SOUND, BURNETT DISPOSABLE
- Applicant
- C.R. Bard, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-10-16
- Decision date
- 1978-12-07
- Days to decision
- 52 days
- Clearance type
- Traditional
- Product code
- HHM
- Device class
- 1
- Regulation number
- 884.4530
- 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 |
|---|---|---|
| CERVILENZ UTERINE MEASURING SOUND (K011840) | Cervilenz, Inc. | 2001-08-10 |
| INTRAUTERINE SOUND (K935665) | Rocket of London, Ltd. | 1994-02-24 |
| ROCKET INTRAUTERINE DEPTH SOUND (K884684) | A & A Medical, Inc. | 1988-12-20 |
| ROCKET INTRAUTERINE SOUND (K883806) | A & A Medical, Inc. | 1988-10-31 |
| TEFLON UTERINE SOUND (K870550) | Cook Ob/Gyn | 1987-03-04 |
| UTERINE SOUND (K840380) | Intl. Medical Technologies, Inc. | 1984-04-30 |
| AUGROS HYSTEROMETER (K831224) | Axcan Scientific Corp. | 1983-10-28 |
| UTERINE SOUND (K802315) | Gynemetrics, Inc. | 1981-01-12 |
| INTRAUTERINE SOUND, PLASTIC DISPOSABLE (K760170) | G.D. Searle and Co. | 1976-07-19 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Covera Vascular Covered Stent (P170042/S014) | C.R. Bard, Inc. | 2025-12-16 |
| Covera Vascular Covered Stents (P170042/S013) | C.R. Bard, Inc. | 2025-06-26 |
| Avitene Microfibrillar Collagen Hemostat (P800002/S033) | C.R. Bard, Inc. | 2025-03-13 |
| AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB (P800002/S032) | C.R. Bard, Inc. | 2025-02-18 |
| Avitene Bulk Flour Cleanroom Expansion (P800002/S031) | C.R. Bard, Inc. | 2024-01-18 |
| Avitene Microfibrillar Collagen Hemostat (P800002/S030) | C.R. Bard, Inc. | 2023-10-04 |
| Covera Vascular Covered Stent (P170042/S012) | C.R. Bard, Inc. | 2023-02-02 |
| Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web and Avitene Microfibrillar Collagen Hemostat (MCH) EndoAvit (P800002/S027) | C.R. Bard, Inc. | 2022-04-01 |