FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SURGICAL LASER ACCESSORIES (SLA) CASE
K Number: K862629
·
Decision Jul 17, 1986
Classifications
1
FEI Numbers
875
Registration Numbers
875
Same Product Code
75
Applicant Total
12
Review Days
7
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Basic Information
- Device Name
- SURGICAL LASER ACCESSORIES (SLA) CASE
- K Number
- K862629
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Simpson/Basye, Inc.
- Date Received
- July 10, 1986
- Decision Date
- July 17, 1986
- Product Code
- FSM
- 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 |
|---|---|---|---|
| FSM | Tray, Surgical, Instrument | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FSM), ordered by most recent decision date.
INSTRUMENT TRAY LINER
FDA 510(k)
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·General, Plastic Surgery
SINGLE USE INSTRUMENT TRAY
FDA 510(k)
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SURGICAL INSTRUMENT TRAY
FDA 510(k)
FDA Class 1
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ARTHROSCOPY TRAY
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OPEN HEART TRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
HEART CATH TRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Simpson/Basye, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K926179 | SEDLACEK HANDLE | Mar 25, 1994 | Substantially Equivalent |
| K891352 | MARLOW ANAL SPECULUM | Jun 23, 1989 | Substantially Equivalent |
| K891351 | NEWPORT LATERAL VAGINAL RETRACTOR | May 11, 1989 | Substantially Equivalent |
| K891347 | REID ENDOCERVICAL SPREADER | Mar 29, 1989 | Substantially Equivalent |
| K891350 | NEWPORT CERVICAL MANIPULATOR | Mar 29, 1989 | Substantially Equivalent |
| K891349 | CAMPION CERVICAL HOOK | Mar 29, 1989 | Substantially Equivalent |
| K891348 | CAMPION LASER FORCEPS | Mar 22, 1989 | Substantially Equivalent |
| K870276 | HEATED INSTRUMENT BATH | May 7, 1987 | Substantially Equivalent |
| K862717 | HAND MIRROR (ENDOSCOPE) | Jul 30, 1986 | Substantially Equivalent |
| K790923 | MI-MARK ENDOCERVICAL SAMPLING SET | Jun 22, 1979 | Substantially Equivalent |