FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SHIELDED TROCAR (OBTURATOR)
K Number: K954774
·
Decision Jun 7, 1996
Classifications
1
FEI Numbers
153
Registration Numbers
153
Same Product Code
337
Applicant Total
7
Review Days
234
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Basic Information
- Device Name
- SHIELDED TROCAR (OBTURATOR)
- K Number
- K954774
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1720
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Gabris Surgical Corp.
- Date Received
- October 17, 1995
- Decision Date
- June 7, 1996
- Product Code
- HET
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HET | Laparoscope, Gynecologic (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by Gabris Surgical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K953548 | LAPAROSCOPIC SURGICAL INSTRUMENT | Sep 19, 1995 | Substantially Equivalent |
| K944640 | LAPAROSCOPIC SURGICAL INSTRUMENT/ACCESSORY KIT | Oct 11, 1994 | Substantially Equivalent |
| K944104 | GABRIS LAPAROSCOPIC SURGICAL KITS | Sep 13, 1994 | Substantially Equivalent |
| K943989 | LAPAROSCOPIC/ENDOSCOPIC INSTRUEMENT | Sep 12, 1994 | Substantially Equivalent |
| K944103 | LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT | Sep 12, 1994 | Substantially Equivalent |
| K930716 | LAPAROSCOPIC CHOLECYSTECTOMY INSTRUMENTATION | Jul 23, 1993 | Substantially Equivalent |