Atlas FDA

MENTOR NOVASILK MESH

FDA 510(k) clearance K053414 · decided 2005-12-27

Clearance details

K-number
K053414
Device name
MENTOR NOVASILK MESH
Applicant
Mentor Corp.
Decision
Substantially Equivalent
Date received
2005-12-07
Decision date
2005-12-27
Days to decision
20 days
Clearance type
Traditional
Product code
OTP
Device class
3
Regulation number
884.5980
Medical specialty
Obstetrics/Gynecology
Advisory committee
Obstetrics/Gynecology
Location
Santa Barbara, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
MENTOR™ MemoryGel™ Silicone Gel-Filled Breast Implants (P030053/S084)Mentor Corp.2025-12-17
MemoryGel™ Silicone Gel-Filled Breast Implants (P030053/S080)Mentor Corp.2025-08-12
MENTOR™ MemoryGel™ Silicone Gel-Filled Breast Implants (P030053/S082)Mentor Corp.2025-08-08
Mentor MemoryGel® Breast Implants (P030053/S072)Mentor Corp.2025-08-06
MENTOR MemoryGel Enhance Breast Implants (P030053/S077)Mentor Corp.2025-07-03
MENTOR™ MemoryGel™ Enhance Breast Implants (P030053/S081)Mentor Corp.2025-06-18
MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTS (P030053/S079)Mentor Corp.2025-05-21
MENTOR™ MemoryGel™ Enhance Breast Implants (P030053/S078)Mentor Corp.2025-02-14