FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES
K Number: K994084
·
Decision Jan 20, 2000
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
25
Applicant Total
529
Review Days
48
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES
- K Number
- K994084
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Smith & Nephew, Inc.
- Date Received
- December 3, 1999
- Decision Date
- January 20, 2000
- Product Code
- FFS
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FFS | Image, Illumination, Fiberoptic, For Endoscope | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FFS), ordered by most recent decision date.
COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PS SERIES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TRU-CABLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACCUTECH ENDOLITE PROBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SOVIS OPTIQUE'S ENDOSCOPIC CABLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MICRO LINK ENDOSCOPIC FIBER CABLE, MODEL B1-90159
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Smith & Nephew, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K254084 | AETOS Shoulder System - CONCELOC Glenoids | Apr 6, 2026 | Substantially Equivalent |
| K252416 | AETOS Shoulder System Meta Humeral Prosthesis Size 0 | Oct 29, 2025 | Substantially Equivalent |
| K252129 | AETOS Shoulder System Stemless Humeral Prosthesis | Oct 3, 2025 | Substantially Equivalent |
| K251627 | BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue) | Jun 25, 2025 | Substantially Equivalent |
| K243608 | TRIGEN Stable Lock Nut & Washer | Jun 12, 2025 | Substantially Equivalent |
| K250677 | LEGION Total Knee System | Apr 2, 2025 | Substantially Equivalent |
| K250571 | CATALYSTEM Femoral Stems | Mar 28, 2025 | Substantially Equivalent |
| K243364 | TRIGEN META-TAN Trochanteric Antegrade Nail | Dec 9, 2024 | Substantially Equivalent |
| K240716 | AETOS Shoulder System Stemless Humeral Prosthesis | Nov 20, 2024 | Substantially Equivalent |
| K242711 | JOURNEY II Unicompartmental Knee System (JOURNEY II UK) | Oct 30, 2024 | Substantially Equivalent |