Atlas FDA

EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM

FDA 510(k) clearance K112386 · decided 2011-09-08

Clearance details

K-number
K112386
Device name
EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM
Applicant
Coloplast Corp.
Decision
Substantially Equivalent
Date received
2011-08-18
Decision date
2011-09-08
Days to decision
21 days
Clearance type
Special
Product code
OTP
Device class
3
Regulation number
884.5980
Medical specialty
Obstetrics/Gynecology
Advisory committee
Obstetrics/Gynecology
Location
Minneapolis, MN, 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.

RecordFirmDate
PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM (K122459)Boston Scientific Corporation2012-12-13
ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION (K121612)American Medical Systems2012-07-20
AMS ELEVATE PC (K112842)American Medical Systems, Inc.2011-10-25
LITE PELVIC FLOOR REPAIR KITS (K103426)Boston Scientific Corp2011-09-14
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
AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM (K083839)C.R. Bard, Inc.2009-01-15

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Titan Inflatable Penile Prosthesis (P000006/S074)Coloplast Corp.2026-07-21
Torosa Saline Filled Testicular Prosthesis (P020003/S012)Coloplast Corp.2026-07-21
Titan Inflatable Penile Prosthesis (P000006/S075)Coloplast Corp.2026-07-20
Titan Inflatable Penile Prosthesis (IPP) (P000006/S072)Coloplast Corp.2026-06-02
Titan Inflatable Penile Prosthesis (P000006/S071)Coloplast Corp.2025-08-14
Titan Inflatable Penile Prosthesis (P000006/S070)Coloplast Corp.2025-05-28
Titan Inflatable Penile Prosthesis (IPP) (P000006/S069)Coloplast Corp.2024-10-02
Titan Inflatable Penile Prosthesis (IPP) (P000006/S068)Coloplast Corp.2024-07-09