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Recon Steerable Sheath

by Serpex Medical, Inc.

510(k) K221302

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK221302 Date15 Aug 2022ClearedStatusActive

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  • Withdrawn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
EOQ
Device class
Class II
Regulation
21 CFR Part 874.4680
Advisory committee
Ear, Nose, Throat
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 22 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 Recon Steerable Sheath is a bronchoscope accessory designed for use with flexible or rigid bronchoscopes. It is classified as a Class II medical device under product code EOQ.

The device received FDA 510(k) clearance (K221302) on August 15, 2022, and is substantially equivalent to a predicate device. It is manufactured by Serpex Medical, Inc. and is intended for use in ear, nose, and throat procedures as indicated by the advisory committee classification.

Devices cleared under K221302

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K221302
UDI-DISize and differences
Recon Steerable Sheath RSS1000
SERPEX MEDICAL, INC.
RSS100000860009430204 —On the market

Similar devices

Other devices filed under FDA product code EOQ (Bronchoscope (Flexible Or Rigid)).

Other devices from Serpex Medical, Inc.

See all devices from Serpex Medical, Inc. →