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Recon Steerable Sheath RSS1000

by Serpex Medical, Inc.

Recon Steerable Sheath RSS1000 is a bronchoscopic catheter (FDA Class II; FDA product code EOQ, Bronchoscope (Flexible Or Rigid)) made by Serpex Medical, Inc., cleared under FDA 510(k) K221302 on 15 Aug 2022 and listed in FDA GUDID since 8 Dec 2025 (UDI-DI 00860009430204), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K221302

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860009430204 UDI-DI Date8 Dec 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK221302 Date15 Aug 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K221302 decided 15 Aug 2022 Active
  • FDA GUDID UDI-DI 00860009430204 listed 8 Dec 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K221302
  2. Listed FDA GUDID 00860009430204

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Recon Steerable Sheath
Generic name
Bronchoscopic catheter
Model / reference
RSS1000
Primary DI / UDI-DI
00860009430204
510(k) Number
FDA product code
EOQ
GMDN term
Bronchoscopic catheter
Device class
Class II
Regulation number
874.4680
GUDID distribution status
In Commercial Distribution

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. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)