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FDA 510(k)

ENTROKIT WITH MAGLINTE CATHETER

K-Number: K860441 · 1986-03-12

ApplicantLafayette Pharmacal, Inc.
Decision Date1986-03-12
Product CodeKGC
Advisory CommitteeGU
DecisionUnknown

Device Summary

ENTROKIT WITH MAGLINTE CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Lafayette Pharmacal, Inc.. It received FDA 510(k) clearance on 1986-03-12 under 510(k) number K860441. The device is classified under product code KGC. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the ENTROKIT WITH MAGLINTE CATHETER?

ENTROKIT WITH MAGLINTE CATHETER is a medical device that received FDA 510(k) clearance on 1986-03-12. The listed applicant is Lafayette Pharmacal, Inc.. The 510(k) number is K860441.

When did ENTROKIT WITH MAGLINTE CATHETER receive FDA 510(k) clearance?

ENTROKIT WITH MAGLINTE CATHETER received FDA 510(k) clearance on 1986-03-12, under 510(k) number K860441.

Who is the listed applicant for ENTROKIT WITH MAGLINTE CATHETER?

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

What is the FDA product code for ENTROKIT WITH MAGLINTE CATHETER?

The FDA product code for ENTROKIT WITH MAGLINTE CATHETER is KGC.

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.

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Other records listing Lafayette Pharmacal, 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.

K931896PRO-FLO SYSTEMK884379MAGLINTE ENTEROCLYSIS CATHETERK881609SITZMARKS

Related Devices (Code: KGC)

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.

K242211PUMA-G Pediatric SystemCoaptech, Inc.K223916PUMA-G SystemCoaptech, Inc.K193612AMT Suture Delivery SystemApplied Medical Technology, Inc.K191844Fidmi Low Profile Enteral Feeding DeviceFidmi Medical, Ltd.K182832Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor SetCook IncorporatedK183057PUMA-G SystemCoaptech, LLC

Official Source

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

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