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FDA 510(k)

LAPAROTOMY BLADDER NECK SUSPENSION KIT

K-Number: K971801 · 1997-07-22

ApplicantLouisville Laboratories, Inc.
Decision Date1997-07-22
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LAPAROTOMY BLADDER NECK SUSPENSION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Louisville Laboratories, Inc.. It received FDA 510(k) clearance on 1997-07-22 under 510(k) number K971801. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAPAROTOMY BLADDER NECK SUSPENSION KIT?

LAPAROTOMY BLADDER NECK SUSPENSION KIT is a medical device that received FDA 510(k) clearance on 1997-07-22. The listed applicant is Louisville Laboratories, Inc.. The 510(k) number is K971801.

When did LAPAROTOMY BLADDER NECK SUSPENSION KIT receive FDA 510(k) clearance?

LAPAROTOMY BLADDER NECK SUSPENSION KIT received FDA 510(k) clearance on 1997-07-22, under 510(k) number K971801.

Who is the listed applicant for LAPAROTOMY BLADDER NECK SUSPENSION KIT?

The FDA 510(k) record lists Louisville Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LAPAROTOMY BLADDER NECK SUSPENSION KIT?

The FDA product code for LAPAROTOMY BLADDER NECK SUSPENSION KIT is EZL.

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Other records listing Louisville Laboratories, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K980123CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SETK971796LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORSK971791VAGINAL SUTURING KIT FOR LAPAROTOMY BLADDER NECK SUSPENSIONK971802VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSIONK971797LAPAROSCOPIC BLADDER NECK SUSPENSION KITK963076LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY

View all 12 devices →

Related Devices (Code: EZL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260756TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)Sentinel Medical Technologies,K262056Rusch Latex Gold Foley CatheterTeleflex Medical Sdn. Bhd.K252537Rusch SoftSimplastic Foley CathetersTeleflex Medical Sdn. Bhd.K243011Silicone Urethral Catheter (Silicone Urethral Catheter)Guangdong Ecan Medical Co., Ltd.K241424InnoCare Specialty Foley CatheterInnocare Urologics, LLCK232469Rüsch Latex Gold Foley CatheterTeleflexmedical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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