Surgical Direct SD23360

by Surgical Direct, Inc.

Surgical Direct SD23360 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 23 Nov 2022 (UDI-DI B382SD233600), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberB382SD233600 UDI-DI	Date23 Nov 2022Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK974382	Date21 Apr 1998Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K974382

Across registries

2 registries list this device

FDA 510(k) K974382 decided 21 Apr 1998 Active
FDA GUDID UDI-DI B382SD233600 listed 23 Nov 2022 Listed

Timeline

2 dated events

21 Apr 1998 Cleared FDA 510(k) K974382
23 Nov 2022 Listed FDA GUDID B382SD233600

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Surgical Direct
Generic name: Flexible endoscopic biopsy forceps, reusable
Model / Ref / Catalog: SD23360

Primary DI / UDI-DI: B382SD233600
510(k) Number: K974382
FDA product code: GCJ
GMDN term: Flexible endoscopic biopsy forceps, reusable

Device class: Class II
Regulation number: 876.1500
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

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Properties

Sterilise before use
Lot / batch number

Other properties (13, all answered No)