# Louisville Laboratories, Inc.

- Location (FDA's records): Louisville, KY
- FDA decisions: 12 (1989–1998): 12 510(k) clearances
- Product codes: HET (2), GCJ (2), EZL (2), MBI (2), CBF (1), FMF (1), BZT (1), EZC (1)
- Predicates its devices cite: 11 (5 its own); citations of its devices by later devices: 18 (5 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Laurus Medical Corp.: 3 (https://510kreport.com/company/laurus-medical)
- Vesitec Medical, Inc.: 3 (https://510kreport.com/company/vesitec-medical)

## Firms that cite its devices most
- Medworks Corp.: 6 (https://510kreport.com/company/medworks)
- Applied Medical Technology, Inc.: 1 (https://510kreport.com/company/applied-medical-technology)
- Surx, Inc.: 1 (https://510kreport.com/company/surx)
- Sterilmed, Inc.: 1 (https://510kreport.com/company/sterilmed)
- Ascent Healthcare Solutions: 1 (https://510kreport.com/company/ascent-healthcare-solutions)
- Safepath Medical, Inc.: 1 (https://510kreport.com/company/safepath-medical)
- Suzhou Shenyun Medical Equipment Co., Ltd.: 1 (https://510kreport.com/company/suzhou-shenyun-medical-equipment)
- Inlet Medical, Inc.: 1 (https://510kreport.com/company/inlet-medical)

## Its most-cited devices
- K963076: Laparoscopic Bone Anchored Urethropexy Instrument Tray (1997), cited by 6
- K980123: Carter-Thomason Needle-Point Suture Passer Instrument Set (1998), cited by 6
- K971797: Laparoscopic Bladder Neck Suspension Kit (1997), cited by 2
- K971801: Laparotomy Bladder Neck Suspension Kit (1997), cited by 1
- K971802: Vaginal Suturing Kit for Bladder Neck Suspension (1997), cited by 1
- K971791: Vaginal Suturing Kit for Laparotomy Bladder Neck Suspension (1997), cited by 1

## Recent decisions
- K980123: Carter-Thomason Needle-Point Suture Passer Instrument Set (Mar 9, 1998)
- K971796: Laparotomy Bladder Neck Suspension Kit with Bone Anchors (Aug 12, 1997)
- K971802: Vaginal Suturing Kit for Bladder Neck Suspension (Jul 30, 1997)
- K971791: Vaginal Suturing Kit for Laparotomy Bladder Neck Suspension (Jul 30, 1997)
- K971797: Laparoscopic Bladder Neck Suspension Kit (Jul 22, 1997)
- K971801: Laparotomy Bladder Neck Suspension Kit (Jul 22, 1997)
- K963076: Laparoscopic Bone Anchored Urethropexy Instrument Tray (Apr 4, 1997)
- K960882: Control Syringe (Jul 8, 1996)

Source page: https://510kreport.com/company/louisville-laboratories