FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MARLOW VERRES NEEDLES
K Number: K913586
·
Decision Oct 8, 1991
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
46
Applicant Total
28
Review Days
57
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Basic Information
- Device Name
- MARLOW VERRES NEEDLES
- K Number
- K913586
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Marlo Surgical Technology
- Date Received
- August 12, 1991
- Decision Date
- October 8, 1991
- Product Code
- GCT
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| GCT | Light Source, Endoscope, Xenon Arc | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Marlo Surgical Technology
| K Number | Device Name | ||
|---|---|---|---|
| K960810 | BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X 35MM | Oct 21, 1996 | Substantially Equivalent |
| K962273 | MALLEABLE STYLET 18 CM ME1816ST, 23 CM ME1816NST | Jul 31, 1996 | Substantially Equivalent |
| K924611 | IRRIGATION PUMP AND TUBING SET | Jun 30, 1994 | Substantially Equivalent |
| K932634 | NU-TIP(TM) FORCEPS:GRASPERS/DISSECTORS/SUTURES | Feb 25, 1994 | Substantially Equivalent |
| K932832 | PRIMUS INSULATED FORCEPS | Feb 25, 1994 | Substantially Equivalent |
| K920611 | MARLOW LAPAROSCOPIC GRASPING FORCEP | Apr 20, 1993 | Substantially Equivalent |
| K914153 | OTT INSUFFLATOR FILTER PLUS/TUBING SET | Apr 2, 1992 | Substantially Equivalent |
| K914869 | MARLOW LAPAROSCOPIC SCISSORS | Jan 15, 1992 | Substantially Equivalent |
| K913954 | MARLOW/REDDICK LAPAROSCOPIC NEEDLE HOLDERS | Dec 18, 1991 | Substantially Equivalent |
| K914872 | MARLOW SUCTION/IRRIGATION PROBES | Nov 19, 1991 | Substantially Equivalent |