FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD8403140
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD840-314
Catalog number
SD840-314
Device description
4mm 30° Sinuscope, Autoclavable, HD, German Made, 140mm Length, Storz Fit
Published
2025-09-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRXArthroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K031972000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031972000ASAP ARTHROSCOPE MODELS; 10-0001-00, 10-0002-00, 10-0003-00, 10-0004-00, 10-0005-00, 10-0006-00, 10-0007-00, 10-0008-00,Asap Endoscopic Products GmbH2003-09-15HRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD8403140PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Rigid video laparoscopeAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the organs/structures of the abdominal/retroperitoneal cavity. It is inserted through a dedicated incision made in the abdominal wall during laparoscopy. Images are transmitted by a camera/video system to a monitor for viewing by the user. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 (800) 519-3293info@surgicaldirect.com

Regulatory Flags#

DUNS number
124367223
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B382SD9226391030Surgical DirectSD922639103SD9226391032023-02-22
B382SD9192442700Surgical DirectSD919244270SD9192442702022-12-01
B382SD48155416201210Surgical DirectSD4815541620-121SD4815541620-1212022-11-30
B382SD180190Surgical DirectSD18019SD180192020-04-29
B382SD180290Surgical DirectSD18029SD180292020-04-28
B382SD182490Surgical DirectSD18249SD182492020-04-29
B382SD182590Surgical DirectSD18259SD182592020-04-25
B382S25681060Surgical DirectS2568.106S2568.1062026-07-29
B382S340861270Surgical DirectS34086.127S34086.1272026-07-29
B382SD90557818E0Surgical DirectSD90557818ESD90557818E2026-07-29
B382SD90712216T0Surgical DirectSD90712216TSD90712216T2026-07-29
B382SD914709040Surgical DirectSD91470904SD914709042026-07-29
B382SD919327220Surgical DirectSD91932720SD919327202026-07-29
B382SD919327230Surgical DirectSD91932723SD919327232026-07-29
B382SD919523070Surgical DirectSD91952307SD919523072026-07-29
B382SD919523080Surgical DirectSD91952308SD919523082026-07-29
B382SD9196141000Surgical DirectSD919614100SD9196141002026-07-29
B382SD9196141010Surgical DirectSD919614101SD9196141012026-07-29
B382SD9200321000Surgical DirectSD920032100SD9200321002026-07-29
B382SD9200321060Surgical DirectSD920032106SD9200321062026-07-29

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Primary DI, Brand, Company table
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08809695579813Trocar Needle (Working Channel)GS Medical Co., Ltd.HRX2026-07-27
08809695579820Bevel Needle (Working Channel)GS Medical Co., Ltd.HRX2026-07-27
00190776422059MillenniumAvalign Technologies, Inc.HRX2026-07-24
00190776422066MillenniumAvalign Technologies, Inc.HRX2026-07-24
10810004821085Spinal Needle SetCLARUS MEDICAL, LLCHRX2026-06-23
10810004821146Curved Cannula SetCLARUS MEDICAL, LLCHRX2026-06-23
00810004821101Digital SpineScope EndoscopeCLARUS MEDICAL, LLCHRX2026-06-22
10810004821122Spinal Introducer SetCLARUS MEDICAL, LLCHRX2026-06-22
00846338001209IEC BiPolar Cable, DisposableELLIQUENCE, LLCHRX2026-06-03
00846338001230Bipolar CableELLIQUENCE, LLCHRX2026-06-03
00846338001247Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCHRX2026-06-03
00846338001537Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCHRX2026-06-03
00846338001582IEC Power Cord 110vELLIQUENCE, LLCHRX2026-06-03
00846338001605IEC Power Cord 220v ANZ PlugELLIQUENCE, LLCHRX2026-06-03
00846338001612IEC Power Cord 220v EuropeELLIQUENCE, LLCHRX2026-06-03
00846338001629IEC Power Cord U.K. 220vELLIQUENCE, LLCHRX2026-06-03
00846338007140BiPolar Cable, DisposableELLIQUENCE, LLCHRX2026-06-02
00846338005146Neutral PlateELLIQUENCE, LLCHRX2026-06-01
00846338005320Needle PunchELLIQUENCE, LLCHRX2026-06-01
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