FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPIDER SURGICAL INSTRUMENTS, MODELS 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015
K Number: K091697
·
Decision Sep 28, 2009
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
15
Review Days
110
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Basic Information
- Device Name
- SPIDER SURGICAL INSTRUMENTS, MODELS 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015
- K Number
- K091697
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Transenterix, Inc.
- Date Received
- June 10, 2009
- Decision Date
- September 28, 2009
- 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 |
Similar 510(k) Clearances
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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 Transenterix, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K202166 | Senhance Surgical System | Mar 2, 2021 | Substantially Equivalent |
| K200049 | Senhance Surgical System | Mar 9, 2020 | Substantially Equivalent |
| K192877 | Senhance Surgical System | Nov 22, 2019 | Substantially Equivalent |
| K191482 | Senhance Surgical System | Jul 11, 2019 | Substantially Equivalent |
| K182421 | Senhance Ultrasonic System | Jan 11, 2019 | Substantially Equivalent |
| K183098 | Senhance Surgical System | Dec 6, 2018 | Substantially Equivalent |
| K181517 | Senhance Surgical System | Oct 9, 2018 | Substantially Equivalent |
| K180163 | TransEnterix Senhance Surgical System | May 25, 2018 | Substantially Equivalent |
| K171120 | Senhance Surgical Robotic System | Oct 13, 2017 | Substantially Equivalent |
| K122299 | SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR GRASPER WAVY RATCHETED, SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR | Oct 25, 2012 | Substantially Equivalent |