FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INTRAOCULAR MICROSCISSORS BY MEANS OF GAMMA RADIA.
K Number: K897093
·
Decision Apr 4, 1990
Classifications
1
FEI Numbers
261
Registration Numbers
261
Same Product Code
14
Applicant Total
12
Review Days
105
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Basic Information
- Device Name
- INTRAOCULAR MICROSCISSORS BY MEANS OF GAMMA RADIA.
- K Number
- K897093
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Microline Pentax, Inc.
- Date Received
- December 20, 1989
- Decision Date
- April 4, 1990
- Product Code
- HNF
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| HNF | Scissors, Ophthalmic | FDA class 1 | Ophthalmic |
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Other Clearances by Microline Pentax, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K982984 | ACCUSHEAR LAPAROSCOPIC SURGICAL INSTRUMENTS | Oct 21, 1998 | Substantially Equivalent |
| K981389 | DISPOSABLE RE-NEW FORCEPS | May 29, 1998 | Substantially Equivalent |
| K981188 | ELECTROSURGICAL CAUTERY PROBES | May 20, 1998 | Substantially Equivalent |
| K980758 | 3 MM SELEC-TIP LAPAROSCOPIC SCISSORS | Mar 27, 1998 | Substantially Equivalent |
| K974066 | RE-NEW FORCEPS LAPAROSCOPIC SURGICAL TIPS | Jan 22, 1998 | Substantially Equivalent |
| K970826 | SELECTA-TIP LAPAROSCOPIC SCISSORS | Mar 28, 1997 | Substantially Equivalent |
| K962119 | RE-NEW LAPAROSCOPIC INSTRUMENTS | Aug 9, 1996 | Substantially Equivalent |
| K932648 | QUICK SWITCH LAPAROSCOPIC INSTRUMENTS | Oct 12, 1993 | Substantially Equivalent |
| K881049 | BRADBURY INTRAOCULAR RETINAL KIT CAT #200 | Sep 12, 1988 | Substantially Equivalent |