FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LAPAROSCOPIC BLADDER NECK SUSPENSION KIT
K Number: K971797
·
Decision Jul 22, 1997
Classifications
1
FEI Numbers
153
Registration Numbers
153
Same Product Code
337
Applicant Total
12
Review Days
68
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Basic Information
- Device Name
- LAPAROSCOPIC BLADDER NECK SUSPENSION KIT
- K Number
- K971797
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1720
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Louisville Laboratories, Inc.
- Date Received
- May 15, 1997
- Decision Date
- July 22, 1997
- 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 Louisville Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K980123 | CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET | Mar 9, 1998 | Substantially Equivalent |
| K971796 | LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORS | Aug 12, 1997 | Substantially Equivalent |
| K971791 | VAGINAL SUTURING KIT FOR LAPAROTOMY BLADDER NECK SUSPENSION | Jul 30, 1997 | Substantially Equivalent |
| K971802 | VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION | Jul 30, 1997 | Substantially Equivalent |
| K971801 | LAPAROTOMY BLADDER NECK SUSPENSION KIT | Jul 22, 1997 | Substantially Equivalent |
| K963076 | LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY | Apr 4, 1997 | Substantially Equivalent |
| K960882 | CONTROL SYRINGE | Jul 8, 1996 | Substantially Equivalent |
| K955535 | LOUISVILLE LABS OXYGEN HEAD TENT | Jul 1, 1996 | Substantially Equivalent |
| K946282 | UNIVERSAL URETHRAL CATHETER | Mar 31, 1995 | Substantially Equivalent |
| K932979 | EXTERNAL STABILITY PAD | Nov 2, 1993 | Substantially Equivalent |