FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURGICAL LIGHT - CHALLENGE 22 SERIES
K Number: K761018
·
Decision Jan 26, 1977
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
4
Applicant Total
19
Review Days
77
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 - CHALLENGE 22 SERIES
- K Number
- K761018
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4580
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Amsco Co.
- Date Received
- November 10, 1976
- Decision Date
- January 26, 1977
- 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
SURGICAL LIGHT 22 SERIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HANDLES, LIGHT, SURGICAL, STEOILE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Amsco Co.
| K Number | Device Name | ||
|---|---|---|---|
| K912471 | EAGLE 3000 SDS | Jun 26, 1992 | Substantially Equivalent |
| K854922 | AMSCO POLARIS SL | Jan 24, 1986 | Substantially Equivalent |
| K833187 | HALL OSTEON | Oct 31, 1983 | Substantially Equivalent |
| K832945 | EAGLE 2000 STERILIZER SERIES GAS/AERA | Oct 19, 1983 | Substantially Equivalent |
| K832188 | HALL RECIPROCATOR | Aug 12, 1983 | Substantially Equivalent |
| K832187 | HALL OSCILLATOR | Aug 12, 1983 | Substantially Equivalent |
| K831086 | CEILING MOUNTED SUPPORT | Aug 12, 1983 | Substantially Equivalent |
| K832186 | HALL DRILL/REAMER | Aug 12, 1983 | Substantially Equivalent |
| K831309 | DELIVERY 4 TABLE | Jun 15, 1983 | Substantially Equivalent |
| K823360 | SURGICAL LIGHT | Dec 3, 1982 | Substantially Equivalent |