FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CASTLE(R) 2510 & 2610 MINOR SURG. LIGHT
K Number: K820681
·
Decision Apr 15, 1982
Classifications
1
FEI Numbers
68
Registration Numbers
68
Same Product Code
73
Applicant Total
37
Review Days
35
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
- CASTLE(R) 2510 & 2610 MINOR SURG. LIGHT
- K Number
- K820681
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4580
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Sybron Corp.
- Date Received
- March 11, 1982
- Decision Date
- April 15, 1982
- Product Code
- FSY
- 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 |
|---|---|---|---|
| FSY | Light, Surgical, Ceiling Mounted | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FSY), ordered by most recent decision date.
Leo Minor
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CLAVEGUARD FREEDOM SURGICAL LIGHT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MI-750 PROCEDURAL/MINOR SURGICAL LIGHT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ZF 720
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MACH LED 2SC
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Sybron Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K862284 | SEALITE | Jun 23, 1986 | Substantially Equivalent |
| K854855 | PROOF ALGINATE IMPRESSION MATERIAL | Jan 30, 1986 | Substantially Equivalent |
| K844092 | DIAGNOSTIC MICROSOPCE SLIDES | Oct 25, 1984 | Substantially Equivalent |
| K842132 | TYCOS SELF-CHECK/DIGITAL FEVER THERMO | Jul 18, 1984 | Substantially Equivalent |
| K841910 | KERR SEALAPEX ROOT CANAL SEALER | Jul 13, 1984 | Substantially Equivalent |
| K841732 | LIEBEL-FLARSHEIM AFC 1000 X-RAY FILM | Jun 5, 1984 | Substantially Equivalent |
| K840469 | TYCOS SELF CHECK BPM3 BLOOD PRESS MONI | May 21, 1984 | Substantially Equivalent |
| K840407 | KERR RESIN BONDED BRIDGE CEMENT | May 21, 1984 | Substantially Equivalent |
| K840607 | LF MOTORIZED RADIOGRAPHIC FILM VIEWER | Mar 5, 1984 | Substantially Equivalent |
| K833138 | DIGITAL INJECTOR SYS | Nov 14, 1983 | Substantially Equivalent |