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Surgical Direct SD812-85

by Surgical Direct, Inc.

Surgical Direct SD812-85 is a Class II device made by Surgical Direct, Inc., cleared under FDA 510(k) K031972 on 15 Sep 2003 and listed in FDA GUDID since 30 Nov 2022 (UDI-DI B382SD812850), 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) K031972

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 NumberB382SD812850 UDI-DI Date30 Nov 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK031972 Date15 Sep 2003DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K031972 decided 15 Sep 2003 Active
  • FDA GUDID UDI-DI B382SD812850 listed 30 Nov 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K031972
  2. Listed FDA GUDID B382SD812850

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  • Withdrawn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
Flexible fibreoptic ureteroscope
Model / Ref / Catalog
SD812-85
Primary DI / UDI-DI
B382SD812850
510(k) Number
FDA product code
HRX
GMDN term
Flexible fibreoptic ureteroscope
Device class
Class II
Regulation number
888.1100
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Flexible fibreoptic ureteroscope

Cleared under the same submission (K031972)

and 8 more cleared under K031972

Similar devices

Other devices filed under FDA product code HRX (Arthroscope).

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)