FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STRYKER HUMMER II MICRODEBRIDER SYSTEM
K Number: K972584
·
Decision Oct 1, 1997
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
90
Applicant Total
101
Review Days
83
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
- STRYKER HUMMER II MICRODEBRIDER SYSTEM
- K Number
- K972584
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4250
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stryker Endoscopy
- Date Received
- July 10, 1997
- Decision Date
- October 1, 1997
- Product Code
- ERL
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ERL), ordered by most recent decision date.
Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
hekaDrill
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ORiGO System
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
AMADEO, M-UK1015 (incl. attachments and accessories)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Celeris, Disposable Sinus Debrider
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
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 |