FDA 510(k) clearance · back to tracker

EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM

Coloplast Corp. cleared K112386 on 2011-09-08, decision: substantially equivalent

K-number

K112386

Sponsor

Coloplast Corp.

Device

EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM

Class

Class III

Decision

Substantially Equivalent

Decision date

2011-09-08

Product code

OTP

Advisory committee

Obstetrics/Gynecology

Medical specialty

Obstetrics/Gynecology

Regulation number

884.5980

Official FDA record

Open K112386on 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 K112386 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.