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Surgical Direct SD42059.100

by Surgical Direct, Inc.

Surgical Direct SD42059.100 is a Class II device made by Surgical Direct, Inc., cleared under FDA 510(k) K974382 on 21 Apr 1998 and listed in FDA GUDID since 30 Nov 2022 (UDI-DI B382SD420591000), 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) K974382

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 NumberB382SD420591000 UDI-DI Date30 Nov 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK974382 Date21 Apr 1998DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K974382 decided 21 Apr 1998 Active
  • FDA GUDID UDI-DI B382SD420591000 listed 30 Nov 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K974382
  2. Listed FDA GUDID B382SD420591000

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  • Withdrawn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
Rigid optical cystoscope
Model / Ref / Catalog
SD42059.100
Primary DI / UDI-DI
B382SD420591000
510(k) Number
FDA product code
GCJ
GMDN term
Rigid optical cystoscope
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Rigid optical cystoscope

Cleared under the same submission (K974382)

and 8 more cleared under K974382

Similar devices

Other devices filed under FDA product code GCJ (Laparoscope, general & plastic surgery).

Other devices from Surgical Direct, Inc.

See all devices from Surgical Direct, Inc. →

Properties

  • Sterilise before use
  • Lot / batch number
Other properties (13, all answered No)