FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INNERVUE DIAGNOSTIC SCOPE SYSTEM
K Number: K040604
·
Decision Jun 4, 2004
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
17
Review Days
88
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Basic Information
- Device Name
- INNERVUE DIAGNOSTIC SCOPE SYSTEM
- K Number
- K040604
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Arthrotek, Inc.
- Date Received
- March 8, 2004
- Decision Date
- June 4, 2004
- 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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FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air)
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Other Clearances by Arthrotek, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K061776 | ARTHROTEK MAXFIRE MENISCAL REPAIR DEVICE | Sep 25, 2006 | Substantially Equivalent |
| K061801 | 2.8 & 3.5MM LACTOSCREW SUTURE ANCHORS | Aug 7, 2006 | Substantially Equivalent |
| K061657 | HITCH LACTOSORB SUTURE ANCHOR | Jul 25, 2006 | Substantially Equivalent |
| K061389 | ALLTHREAD LACTOSORB SUTURE ANCHOR | Jul 19, 2006 | Substantially Equivalent |
| K060693 | MICROSTRIKE AND ALLTHREAD PEEK SUTURE ANCHOR | Jun 6, 2006 | Substantially Equivalent |
| K053461 | EZLOC FEMORAL FIXATION DEVICE | Feb 3, 2006 | Substantially Equivalent |
| K051069 | NONRESORBABLE CENTRALOC TIBIAL SCREW & WASHER | Jun 29, 2005 | Substantially Equivalent |
| K042460 | TI - SCREW ANCHOR SP | Oct 29, 2004 | Substantially Equivalent |
| K041274 | RESORBABLE INTERFERENCE SCREW | Jul 28, 2004 | Substantially Equivalent |
| K041261 | FEMORAL HOOK | Jun 7, 2004 | Substantially Equivalent |