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Surgical Direct SD42289

by Surgical Direct, Inc.

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 23 Oct 2026

Documents

510(k) K974382

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB382SD422890 UDI-DI Date25 Apr 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK974382 Date21 Apr 1998DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Surgical Direct
Generic name
Endoscope sheath, reusable
Model / Ref / Catalog
SD42289
Primary DI / UDI-DI
B382SD422890
510(k) Number
FDA product code
GCJ
GMDN term
Endoscope sheath, reusable
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Catheter Gauge — 24 French

Related devices

Category: Endoscope sheath, reusable

Cleared under the same submission (K974382)

Show all (12)

Other devices from Surgical Direct, Inc.

See all devices from Surgical Direct, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number

Other properties (12)

  • Supplied sterile: No
  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No