FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FELDMAN MINI-SAW, #300000
K Number: K800669
·
Decision Apr 21, 1980
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
1
Applicant Total
334
Review Days
26
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
- FELDMAN MINI-SAW, #300000
- K Number
- K800669
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4420
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- Date Received
- March 26, 1980
- Decision Date
- April 21, 1980
- Product Code
- EWQ
- 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 |
|---|---|---|---|
| EWQ | Saw, Surgical, Ent (Electric Or Pneumatic) | FDA class 1 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EWQ), ordered by most recent decision date.
View allOther Clearances by KARL STORZ Endoscopy-America, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252624 | KARL STORZ Laryngoscopes and Accessories | May 15, 2026 | Substantially Equivalent |
| K223923 | HOPKINS Telescopes | Mar 30, 2023 | Substantially Equivalent |
| K202957 | Flexible Video Cysto-Urethroscope (C-view) | Oct 29, 2020 | Substantially Equivalent |
| K200318 | UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece | Oct 22, 2020 | Substantially Equivalent |
| K201135 | Image1 S CCU, Image1 S 4U Camera Head | Sep 1, 2020 | Substantially Equivalent |
| K200740 | HD Video Rhino Laryngoscope | Aug 11, 2020 | Substantially Equivalent |
| K191357 | Flexible HD Cysto-Urethroscope System | Sep 18, 2019 | Substantially Equivalent |
| K182723 | Flexible HD Cysto-Urethroscope System | Apr 23, 2019 | Substantially Equivalent |
| K182186 | CMOS Video-Rhino-Laryngoscope System | Mar 22, 2019 | Substantially Equivalent |
| K183264 | Flex-THOR scope | Jan 18, 2019 | Substantially Equivalent |