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FDA 510(k)

CURITY 100% SILICONE IRRIGATION FOLEY

K-Number: K810691 · 1981-03-13

ApplicantThe Kendal Co.
Decision Date1981-03-13
Product CodeEZL
Advisory CommitteeGU
DecisionUnknown

Device Summary

CURITY 100% SILICONE IRRIGATION FOLEY is the device name listed in this FDA 510(k) record. The listed applicant is The Kendal Co.. It received FDA 510(k) clearance on 1981-03-13 under 510(k) number K810691. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the CURITY 100% SILICONE IRRIGATION FOLEY?

CURITY 100% SILICONE IRRIGATION FOLEY is a medical device that received FDA 510(k) clearance on 1981-03-13. The listed applicant is The Kendal Co.. The 510(k) number is K810691.

When did CURITY 100% SILICONE IRRIGATION FOLEY receive FDA 510(k) clearance?

CURITY 100% SILICONE IRRIGATION FOLEY received FDA 510(k) clearance on 1981-03-13, under 510(k) number K810691.

Who is the listed applicant for CURITY 100% SILICONE IRRIGATION FOLEY?

The FDA 510(k) record lists The Kendal Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CURITY 100% SILICONE IRRIGATION FOLEY?

The FDA product code for CURITY 100% SILICONE IRRIGATION FOLEY is EZL.

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Other records listing The Kendal Co. 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.

K000087MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FRK990500KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946CK991758MONOJECT INSULIN SYRINGEK970969KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SETK951488KENDALL CURITY CATHETER PLUG WITH PROTECTIVE CAPK942664KENDALL MODEL 6325 SCD SEQUEL COMPRESSION SYSTEM

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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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