FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURGICAL LIGHT 22 SERIES
K Number: K781581
·
Decision Oct 17, 1978
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
4
Applicant Total
36
Review Days
32
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
- SURGICAL LIGHT 22 SERIES
- K Number
- K781581
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4580
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- American Sterilizer Co.
- Date Received
- September 15, 1978
- Decision Date
- October 17, 1978
- Product Code
- FQP
- 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 |
|---|---|---|---|
| FQP | Lamp, Operating-Room | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FQP), ordered by most recent decision date.
ACULUX, MODEL AX3001, AX3002
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SYNTHES LIGHT GUIDE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HANDLES, LIGHT, SURGICAL, STEOILE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SURGICAL LIGHT - CHALLENGE 22 SERIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by American Sterilizer Co.
| K Number | Device Name | ||
|---|---|---|---|
| K943288 | AMSCO SQ240 SURGICAL LIGHT | Oct 17, 1994 | Substantially Equivalent |
| K931872 | THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER | Feb 7, 1994 | Substantially Equivalent |
| K922485 | CHEMDI-VHP CHEMICAL INDICATOR | Sep 29, 1993 | Substantially Equivalent |
| K930493 | QUANTUM 3080 SURGICAL TABLE | Jun 22, 1993 | Substantially Equivalent |
| K905816 | ORTHOVISION TABLE | Mar 6, 1991 | Substantially Equivalent |
| K896674 | AMSCO QUANTUM LIGHT | Jan 3, 1990 | Substantially Equivalent |
| K895164 | EAGLE DS | Nov 17, 1989 | Substantially Equivalent |
| K882660 | GENERAL SURGICAL TABLE AND ACCESSORIES | Jul 25, 1988 | Substantially Equivalent |
| K880198 | GEMINI SURGICAL LIGHT | Feb 10, 1988 | Substantially Equivalent |
| K864846 | RADIOGRAPHIC - LEG SECTION | Dec 24, 1986 | Substantially Equivalent |