Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

KENDALL FLAT/ROUND & FLAT SPLITTABLE SILICON DRAIN

K-Number: K925748 · 1993-01-13

ApplicantKendall Healthcare Products Co. Div.Of Tyco Health
Decision Date1993-01-13
Product CodeGBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

KENDALL FLAT/ROUND & FLAT SPLITTABLE SILICON DRAIN is the device name listed in this FDA 510(k) record. The listed applicant is Kendall Healthcare Products Co. Div.Of Tyco Health. It received FDA 510(k) clearance on 1993-01-13 under 510(k) number K925748. The device is classified under product code GBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KENDALL FLAT/ROUND & FLAT SPLITTABLE SILICON DRAIN?

KENDALL FLAT/ROUND & FLAT SPLITTABLE SILICON DRAIN is a medical device that received FDA 510(k) clearance on 1993-01-13. The listed applicant is Kendall Healthcare Products Co. Div.Of Tyco Health. The 510(k) number is K925748.

When did KENDALL FLAT/ROUND & FLAT SPLITTABLE SILICON DRAIN receive FDA 510(k) clearance?

KENDALL FLAT/ROUND & FLAT SPLITTABLE SILICON DRAIN received FDA 510(k) clearance on 1993-01-13, under 510(k) number K925748.

Who is the listed applicant for KENDALL FLAT/ROUND & FLAT SPLITTABLE SILICON DRAIN?

The FDA 510(k) record lists Kendall Healthcare Products Co. Div.Of Tyco Health as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KENDALL FLAT/ROUND & FLAT SPLITTABLE SILICON DRAIN?

The FDA product code for KENDALL FLAT/ROUND & FLAT SPLITTABLE SILICON DRAIN is GBX.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Kendall Healthcare Products Co. Div.Of Tyco Health 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.

K973763KENDALL CURITY IODOFORM PACKING STRIPK973511KENDALL CURITY PETROLATUM GAUZEK973507KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)K973619KENDALL CURITY NON-ADHERING DRESSINGK973509KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSINGK973546KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER

View all 66 devices →

Related Devices (Code: GBX)

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.

K082725GRAFTGUARD PRESSURE CONTROLLING SYRINGEMaquet Cardiovascular, LLCK052286DEUTSCH ANTI-BLOCKAGE WOUND DRAINThe Catheter Exchange, Inc.K043515GRAFTSAVERVescare, Inc.K013417MISONIX IRRIGATION SYSTEM MOEDL BC20PMisonix, Inc.K000704DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)Dmc Medical, Ltd.K974233LYSONIX IRRIGATION SYSTEMLysonix, 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.

↑