FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Q-5000
K Number: K961971
·
Decision Jun 28, 1996
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
19
Applicant Total
101
Review Days
39
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
- Q-5000
- K Number
- K961971
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4580
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stryker Endoscopy
- Date Received
- May 20, 1996
- Decision Date
- June 28, 1996
- Product Code
- FSS
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FSS | Light, Surgical, Floor Standing | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FSS), ordered by most recent decision date.
ILED 3 MOBILE (I300M), TRULIGHT 5500 MOBILE (T500M), TRULIGHT 5300 MOBILE (T300M)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGERY LIGHT; NEXT GENERATION SPOTLIGHT; NEXT GENERATION M8
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AESCULAP XENON LIGHT SOURCE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CERMAX300 LIGHTSOURCE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Stryker Endoscopy
| K Number | Device Name | ||
|---|---|---|---|
| K253602 | Precision S 4K Sinuscope | Jun 4, 2026 | Substantially Equivalent |
| K261037 | 780 nm SPY Portable Handheld Imaging (SPY-PHI) System | May 28, 2026 | Substantially Equivalent |
| K260185 | 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality | Feb 18, 2026 | Substantially Equivalent |
| K260108 | L12 LED Light Source with AIM | Feb 12, 2026 | Substantially Equivalent |
| K254014 | Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control | Jan 13, 2026 | Substantially Equivalent |
| K253888 | MOLLI 2 System | Dec 31, 2025 | Substantially Equivalent |
| K252010 | SPY Laparoscope | Jul 24, 2025 | Substantially Equivalent |
| K252012 | SPY Cystoscope/Hysteroscope | Jul 18, 2025 | Substantially Equivalent |
| K250544 | Knotilus+ Biocomposite Knotless Anchor | May 23, 2025 | Substantially Equivalent |
| K250528 | Stryker AlphaVent Knotless SP Biocomposite Anchor | May 21, 2025 | Substantially Equivalent |