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Surgical Direct SD8453115

by Surgical Direct, Inc.

Surgical Direct SD8453115 is a Class II device made by Surgical Direct, Inc., cleared under FDA 510(k) K021931 on 6 Sep 2002 and listed in FDA GUDID since 25 Apr 2020 (UDI-DI B382SD84531150), active as of 23 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 23 Oct 2026

Documents

510(k) K021931

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB382SD84531150 UDI-DI Date25 Apr 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK021931 Date6 Sep 2002DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K021931 decided 6 Sep 2002 Active
  • FDA GUDID UDI-DI B382SD84531150 listed 25 Apr 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K021931
  2. Listed FDA GUDID B382SD84531150

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  • Withdrawn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
Fibreoptic light cable, reusable
Model / Ref / Catalog
SD8453115
Description
5mm 10' Autoclavable Fiber Optic Light Cable, Blue ..Light Source Type: Wolf, Dyonics, and Stryker X8000 and L9000..Scope Type: Acmi/Circon, Bare Post Clip On
Primary DI / UDI-DI
B382SD84531150
510(k) Number
FDA product code
FFS
GMDN term
Fibreoptic light cable, reusable
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Length — 10 Feet
Outer Diameter — 5 Millimeter

Related devices

Category: Fibreoptic light cable

Cleared under the same submission (K021931)

and 8 more cleared under K021931

Similar devices in this category

Other devices filed under Fibreoptic light cable.

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, all answered No)