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Readyswim

by Nidacon International Ab

510(k) K011346

Readyswim is a medical device (FDA Class II; FDA product code MQL, Media, Reproductive) made by Nidacon International Ab, cleared under FDA 510(k) K011346 on 28 Jun 2001, active as of 12 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 12 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 12 Oct 2026.

Regulatory status

as of registry sync 12 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK011346 Date28 Jun 2001ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
MQL
Device class
Class II
Regulation
21 CFR Part 884.6180
Advisory committee
Obstetrics/Gynecology
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code MQL (Media, Reproductive).

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