FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HAND MIRROR (ENDOSCOPE)
K Number: K862717
·
Decision Jul 30, 1986
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
2
Applicant Total
12
Review Days
13
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Basic Information
- Device Name
- HAND MIRROR (ENDOSCOPE)
- K Number
- K862717
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Simpson/Basye, Inc.
- Date Received
- July 17, 1986
- Decision Date
- July 30, 1986
- Product Code
- GCO
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| GCO | Endoscope, Mirror | FDA class 2 | Gastroenterology, Urology |
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|---|---|---|---|
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| 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 |
| K862629 | SURGICAL LASER ACCESSORIES (SLA) CASE | Jul 17, 1986 | Substantially Equivalent |
| K790923 | MI-MARK ENDOCERVICAL SAMPLING SET | Jun 22, 1979 | Substantially Equivalent |