FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD8073010
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD807-301
Catalog number
SD807-301
Device description
2.7mm, 30 Degree Arthroscope, 175mm Working Length, Autoclave, High Performance German Optics, Storz
Published
2022-11-30
Public version status
Update
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
B382SD8073010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Rigid arthroscope, reusableAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the interior of a joint (e.g., knee, shoulder, elbow). It is inserted into the body through an artificial orifice created by an incision made during arthroscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. This device is commonly used to examine structural damage to a joint, often from sports injuries. The arthroscope eyepiece is normally interfaced with a video camera. 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
B382SD902511300Surgical DirectSD90251130SD902511302026-07-24
B382SD907394200Surgical DirectSD90739420SD907394202026-07-24
B382SD907581320Surgical DirectSD90758132SD907581322026-07-24
B382SD9141051110Surgical DirectSD914105111SD9141051112026-07-24
B382SD9141071020Surgical DirectSD914107102SD9141071022026-07-24
B382SD9141071030Surgical DirectSD914107103SD9141071032026-07-24
B382SD9141071040Surgical DirectSD914107104SD9141071042026-07-24
B382SD9141551000Surgical DirectSD914155100SD9141551002026-07-24
B382SD914172160Surgical DirectSD91417216SD914172162026-07-24
B382SD9141731000Surgical DirectSD914173100SD9141731002026-07-24
B382SD9141781300Surgical DirectSD914178130SD9141781302026-07-24
B382SD306090Surgical DirectSD30609SD306092022-11-23
B382SD155310120Surgical DirectSD15531012SD155310122026-07-23
B382SD155310140Surgical DirectSD15531014SD155310142026-07-23
B382SD1553600Surgical DirectSD155360SD1553602026-07-23
B382SD9017971040Surgical DirectSD901797104SD9017971042026-07-23
B382SD9029931060Surgical DirectSD902993106SD9029931062026-07-23
B382SD905701100Surgical DirectSD90570110SD905701102026-07-23
B382SD9114061030Surgical DirectSD911406103SD9114061032026-07-23
B382SD911424030Surgical DirectSD91142403SD911424032026-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08809281659301BALEX Bone Expander SystemTaeyeon Medical co.,Ltd.HRX2025-08-22
08809281659325BALEX Bone Expander SystemTaeyeon Medical co.,Ltd.HRX2025-08-22
08809281659370BALEX Bone Expander SystemTaeyeon Medical co.,Ltd.HRX2025-08-22
07613327601695Connected OR HubSTRYKER CORPORATIONHRX2025-06-04
07613327601701SDC4K Information Management SystemSTRYKER CORPORATIONHRX2025-06-04
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07613327638233OmnicurveSTRYKER CORPORATIONHRX2024-09-03
07613327638240OmnicurveSTRYKER CORPORATIONHRX2024-09-03
07613327638257OmnicurveSTRYKER CORPORATIONHRX2024-09-03
07613327638431OmnicurveSTRYKER CORPORATIONHRX2024-09-03
07613327638448OmnicurveSTRYKER CORPORATIONHRX2024-09-03
B235MDK00020mild Device KitSTRYKER CORPORATIONHRX2024-06-19
08800038059313SYNTH™ STANDARDIMEDICOM CO., LTD.HRX2024-03-25