FDA 510(k) clearance · back to tracker

ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION

American Medical Systems cleared K121612 on 2012-07-20, decision: substantially equivalent

K-number

K121612

Sponsor

American Medical Systems

Device

ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION

Class

Class III

Decision

Substantially Equivalent

Decision date

2012-07-20

Product code

OTP

Advisory committee

Obstetrics/Gynecology

Medical specialty

Obstetrics/Gynecology

Regulation number

884.5980

Official FDA record

Open K121612on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

Use this as a predicate

Drop K121612 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

Try the sandbox

Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.