FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURG-FLEX 5 SURGICAL LIGHT
K Number: K810018
·
Decision Jan 23, 1981
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
6
Applicant Total
13
Review Days
18
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Basic Information
- Device Name
- SURG-FLEX 5 SURGICAL LIGHT
- K Number
- K810018
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4580
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Medical Products Development, Inc.
- Date Received
- January 5, 1981
- Decision Date
- January 23, 1981
- Product Code
- FSQ
- 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 |
|---|---|---|---|
| FSQ | Light, Surgical, Instrument | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FSQ), ordered by most recent decision date.
MIDMARK SURGICAL LIGHTING SYSTEMS
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SURG-FLEX 10 LIGHT
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SURG-FLEX 15 SURGICAL LIGHT
FDA 510(k)
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Other Clearances by Medical Products Development, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K810013 | MULTIPERFECTEMP CAUTERY | Apr 23, 1981 | Substantially Equivalent |
| K810012 | MULTIMICRO SURGICAL CAUTERY | Apr 23, 1981 | Substantially Equivalent |
| K810016 | REPLACABLE BATTERY PERFECTEMP CAUTERY | Apr 23, 1981 | Substantially Equivalent |
| K803067 | SURG-FLEX 10 LIGHT | Feb 26, 1981 | Substantially Equivalent |
| K810015 | MULTIHI-TEMP CAUTERY | Feb 12, 1981 | Substantially Equivalent |
| K810014 | REPLACABLE BATTERY HI-TEMP CAUTERY | Feb 12, 1981 | Substantially Equivalent |
| K802942 | HITEMP. TM 2 LOOPTIP CAUTERY | Feb 4, 1981 | Substantially Equivalent |
| K810019 | SURG-FLEX 15 SURGICAL LIGHT | Jan 23, 1981 | Substantially Equivalent |
| K810017 | MICROSURG CAUTERY | Jan 5, 1981 | Unknown |
| K802330 | HI-TEMP LOOPTIP SURGICAL CAUTERY | Nov 12, 1980 | Substantially Equivalent |