Atlas FDA

AVAULTA SUPPORT SYSTEM

FDA 510(k) clearance K082571 · decided 2008-09-30

Clearance details

K-number
K082571
Device name
AVAULTA SUPPORT SYSTEM
Applicant
C.R. Bard, Inc.
Decision
Substantially Equivalent
Date received
2008-09-05
Decision date
2008-09-30
Days to decision
25 days
Clearance type
Special
Product code
OTP
Device class
3
Regulation number
884.5980
Medical specialty
Obstetrics/Gynecology
Advisory committee
Obstetrics/Gynecology
Location
Covington, GA, US
Third-party review
No
Expedited review
No

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EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM (K112386)Coloplast Corp.2011-09-08
SURELIFT PROLAPSE SYSTEM (K102815)Neomedic International2011-07-07
AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE (K111118)American Medical Systems2011-07-01
RESTORELLE POLYPROPYLENE MESH (K092207)Mpathy Medical Devices, Inc.2009-08-04
PELVIC FLOOR REPAIR SYSTEM (K091131)Boston Scientific2009-05-08
EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS (K083499)Coloplast A/S2009-05-08
ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP (K090713)American Medical Systems, Inc.2009-04-02
ASCEND (K083722)Caldera Medical, Inc.2009-03-31

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
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