FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDLINE'S EXAMIN, OPERATING ROOM/SURG LIGHTS/LAMPS
K Number: K931675
·
Decision Feb 22, 1994
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
28
Applicant Total
238
Review Days
322
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
- MEDLINE'S EXAMIN, OPERATING ROOM/SURG LIGHTS/LAMPS
- K Number
- K931675
- 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
- Medline Industries, Inc.
- Date Received
- April 6, 1993
- Decision Date
- February 22, 1994
- Product Code
- FTD
- 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 |
|---|---|---|---|
| FTD | Lamp, Surgical | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FTD), ordered by most recent decision date.
SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VOLISTA 400; VOLISTA 600
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
POLARIS 100/200
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ATRICURE DISSECTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HM-LAMP II
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
STRYKER KNIFELIGHT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Medline Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| DEN210049 | Medline ART Skin Harvesting System | Mar 27, 2024 | Unknown |
| K230559 | Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260) | Oct 26, 2023 | Substantially Equivalent |
| K223100 | Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14) | Jun 27, 2023 | Substantially Equivalent |
| K222665 | Medline UNITE® Ankle Fusion Plating System | Jan 25, 2023 | Substantially Equivalent |
| K213054 | Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe | Dec 9, 2022 | Substantially Equivalent |
| K212911 | Konig Mogen Clamp | Nov 18, 2022 | Substantially Equivalent |
| K220565 | Hudson RCI Triflo II Incentive Deep Breathing Exerciser | Oct 25, 2022 | Substantially Equivalent |
| K213481 | Medline General Surgery Tray | May 24, 2022 | Substantially Equivalent |
| K212093 | Medline Universal Grounding Pad | Jan 14, 2022 | Substantially Equivalent |
| K213068 | Medline Smoke Evacuation Shroud | Jan 3, 2022 | Substantially Equivalent |