FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICROLINE INC. REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS, MODEL M/L-10
K Number: K013695
·
Decision Jan 8, 2002
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
12
Review Days
62
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Basic Information
- Device Name
- MICROLINE INC. REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS, MODEL M/L-10
- K Number
- K013695
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Microline Pentax, Inc.
- Date Received
- November 7, 2001
- Decision Date
- January 8, 2002
- Product Code
- GCJ
- Advisory Committee
- Gastroenterology, Urology
- 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Microline Pentax, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| 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 |