FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OLYMPUS PK TP(TM) SYSTEM, MODIFICATION
K Number: K911640
·
Decision Jul 24, 1991
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
8
Applicant Total
142
Review Days
107
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Basic Information
- Device Name
- OLYMPUS PK TP(TM) SYSTEM, MODIFICATION
- K Number
- K911640
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3830
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Olympus Corp.
- Date Received
- April 8, 1991
- Decision Date
- July 24, 1991
- Product Code
- GMT
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| GMT | Antigens, Ha, Treponema Pallidum | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GMT), ordered by most recent decision date.
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MODIFIED PK TP CONTROL
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OLYMPUS PK-TP ABSORBENT KIT
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CELLOGNOST SYPHILIS H
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OLYMPUS PK(TM) TP
FDA 510(k)
FDA Class 2
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BACTO-HATTS
FDA 510(k)
FDA Class 2
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Other Clearances by Olympus Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K915402 | EW-10 AND EW-20 | Jun 23, 1995 | Substantially Equivalent for Some Indications |
| K933200 | OLYMPUS PBD STENTS | Apr 5, 1995 | Substantially Equivalent |
| K942338 | OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIES | Nov 30, 1994 | Substantially Equivalent |
| K931763 | HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS | Aug 29, 1994 | Substantially Equivalent |
| K934835 | FLOVAL | Jun 21, 1994 | Substantially Equivalent |
| K931764 | HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES | Jun 8, 1994 | Substantially Equivalent |
| K915857 | FLEXIBLE TIP THORACOSCOPE/LAPAROSCOPE | Mar 11, 1994 | Substantially Equivalent |
| K931994 | RESECTOSCOPE SHEATH | Feb 17, 1994 | Substantially Equivalent |
| K933992 | OLYMPUS SCLEROTHERAPY BALLOON | Dec 21, 1993 | Substantially Equivalent |
| K934361 | OLYMPUS CREATININE REAGENT | Nov 16, 1993 | Substantially Equivalent |