OBSTETRICAL PACK (VIGILON OB PACK)
FDA 510(k) clearance K760455 · decided 1976-08-26
Clearance details
- K-number
- K760455
- Device name
- OBSTETRICAL PACK (VIGILON OB PACK)
- Applicant
- C.R. Bard, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1976-08-16
- Decision date
- 1976-08-26
- Days to decision
- 10 days
- Clearance type
- Traditional
- Product code
- HHD
- Device class
- 1
- Regulation number
- 884.5435
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch C.R. Bard
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 |
|---|---|---|
| ALWAYS MENSTRUAL PADS (K071827) | Procter & Gamble, Inc. | 2007-09-20 |
| ALWAYS DUETS (K012629) | Procter & Gamble Co. | 2001-10-05 |
| ENVIVE MINIFORMS (K003843) | Procter & Gamble Co. | 2001-02-08 |
| UNSCENTED INTERLABIAL MENSTRUAL PAD (K993870) | Procter & Gamble Co. | 2000-01-18 |
| GLADRAGS COTTON MENSTRUAL PAD (K980395) | Keepers!, Inc. | 1998-04-16 |
| FLUSHIES FLUSHABLE/BIODEGRADABLE MENSTRUAL PADS/NAPKINS (ULTRA THINS) (K953470) | Mediquip, Inc. | 1995-11-21 |
| UNSCENTED ULTRATHIN MAXI PAD (K953668) | Paragon Trade Brands, Inc. | 1995-11-01 |
| UNSCENTED MENSTRUAL PAD (K953633) | Tendasoft, Inc. | 1995-11-01 |
| UNSCENTED CURVED ULTRATHIN MAXI PADS (K953667) | Paragon Trade Brands, Inc. | 1995-11-01 |
| UNSCENTED MENSTRAL PAD (K953553) | Paragon Trade Brands, Inc. | 1995-10-27 |
| UNSCENTED MENSTRUAL PAD (K953517) | Paragon Trade Brands, Inc. | 1995-10-26 |
| UNSCENTED CURVED MAXI PAD (K953700) | Paragon Trade Brands, Inc. | 1995-09-27 |
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 |