Laparoscopic Bone Anchored Urethropexy Instrument Tray
FDA 510(k) K963076 · Louisville Laboratories, Inc.
510(k) numberK963076
Submission
- Device name
- Laparoscopic Bone Anchored Urethropexy Instrument Tray
- Applicant
- Louisville Laboratories, Inc.
Louisville, KY, US - Received
- August 7, 1996
- Decision date
- April 4, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HET – Laparoscope, Gynecologic (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1720
- Specialty
- Obstetrics/Gynecology
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More from 270surgical , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K980123 | Carter-Thomason Needle-Point Suture Passer Instrument SetGCJ · Traditional | 03/09/1998SE |
| K971796 | Laparotomy Bladder Neck Suspension Kit with Bone AnchorsEZL · Traditional | 08/12/1997SE |
| K971802 | Vaginal Suturing Kit for Bladder Neck SuspensionMBI · Traditional | 07/30/1997SE |
| K971791 | Vaginal Suturing Kit for Laparotomy Bladder Neck SuspensionMBI · Traditional | 07/30/1997SE |
| K971801 | Laparotomy Bladder Neck Suspension KitEZL · Traditional | 07/22/1997SE |
| K971797 | Laparoscopic Bladder Neck Suspension KitHET · Traditional | 07/22/1997SE |
| K960882 | Control SyringeFMF · Traditional | 07/08/1996SE |
| K955535 | Louisville Labs Oxygen Head TentCBF · Traditional | 07/01/1996SE |
| K946282 | Universal Urethral CatheterEZC · Traditional | 03/31/1995SE |
| K932979 | External Stability PadGCJ · Traditional | 11/02/1993SE |
Questions and answers
When was Laparoscopic Bone Anchored Urethropexy Instrument Tray cleared by the FDA?
Laparoscopic Bone Anchored Urethropexy Instrument Tray (K963076) received a 510(k) decision of Substantially Equivalent on April 4, 1997, 240 days after the submission was received.
What is the product code of K963076?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.