FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACCUSHEAR LAPAROSCOPIC SURGICAL INSTRUMENTS
K Number: K982984
·
Decision Oct 21, 1998
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
12
Review Days
56
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Basic Information
- Device Name
- ACCUSHEAR LAPAROSCOPIC SURGICAL INSTRUMENTS
- K Number
- K982984
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Microline Pentax, Inc.
- Date Received
- August 26, 1998
- Decision Date
- October 21, 1998
- Product Code
- GEI
- 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Microline Pentax, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K013695 | MICROLINE INC. REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS, MODEL M/L-10 | Jan 8, 2002 | 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 |
| K897093 | INTRAOCULAR MICROSCISSORS BY MEANS OF GAMMA RADIA. | Apr 4, 1990 | Substantially Equivalent |
| K881049 | BRADBURY INTRAOCULAR RETINAL KIT CAT #200 | Sep 12, 1988 | Substantially Equivalent |