Atlas FDA

RESTORELLE POLYPROPYLENE MESH

FDA 510(k) clearance K092207 · decided 2009-08-04

Clearance details

K-number
K092207
Device name
RESTORELLE POLYPROPYLENE MESH
Applicant
Mpathy Medical Devices, Inc.
Decision
Substantially Equivalent
Date received
2009-07-22
Decision date
2009-08-04
Days to decision
13 days
Clearance type
Special
Product code
OTP
Device class
3
Regulation number
884.5980
Medical specialty
Obstetrics/Gynecology
Advisory committee
Obstetrics/Gynecology
Location
Glasgow, GB
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Mpathy Medical Devices

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.

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
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
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.