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Confluent Surgical Micromyst Applicator and Air Pump, Models 20-5000, AP-A-6063

by Confluent Surgical, Inc

510(k) K050998

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK050998 Date15 Jun 2005ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
FMF
FDA applicant
Confluent Surgical,Inc
Device Class
Class II
Regulation
21 CFR Part 880.5860
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Confluent Surgical Micromyst Applicator and Air Pump is a device indicated for use in the simultaneous delivery of two non-homogenous fluids or solutions onto a surgical site. It is classified under product code FMF and was determined to be substantially equivalent to a predicate device through the FDA 510(k) process.

The device received FDA 510(k) clearance on June 15, 2005, under K number K050998, and is classified as a Class II medical device. It is intended for use in general hospital settings and was manufactured by Confluent Surgical, Inc. No information regarding sterility, single-use or reusable status, MRI safety, sizes, storage conditions, or additional authorisations is provided in the supplied data.

Other devices from Confluent Surgical, Inc

Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical purpose does the Confluent Micromyst Applicator and Air Pump serve?

    It is intended to deliver two different, non‑homogenous fluids or solutions at the same time directly onto a surgical site, allowing clinicians to apply combined treatments such as irrigants and medicaments without needing separate instruments.

  • How is the device supplied and identified?

    The product is offered as the Micromyst Applicator and Air Pump under model range 20‑5000, with the specific reference AP‑A‑6063. This model identifier distinguishes it from other Confluent Surgical products and is used in ordering and inventory.

  • Is the Micromyst Applicator and Air Pump a single‑use or reusable device?

    The supplied data do not specify sterility or reuse status, so the device’s classification as single‑use or reusable cannot be confirmed from the available information. Users should consult the manufacturer’s labeling for that detail.

  • What regulatory clearance does this device have?

    The device received traditional FDA 510(k) clearance (K050998) on June 15 2005, classifying it as a Class II medical device. This indicates it was found substantially equivalent to a predicate device under the FMF product code.

  • In what settings is the Micromyst Applicator and Air Pump intended to be used?

    It is intended for use in general hospital environments, where surgical teams can employ it to apply two fluids simultaneously during operative procedures, supporting a range of intra‑operative applications.