Product Code: FEW FDA class 2 21 CFR 876.5090

Catheter, Malecot

Gastroenterology, Urology

The Malecot Catheter is a urological drainage catheter with a winged or flanged tip design used to maintain drainage from the kidney, bladder, or other anatomical sites. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is FEW, regulated under 21 CFR 876.5090, within the Gastroenterology, Urology specialty. This device is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: FEW
Device Class: FDA class 2
Regulation Number: 876.5090
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 6 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K140085	UNIVERSA PERCULTANEOUS DRAINAGE CATHETER	Nov 18, 2014	Substantially Equivalent	Cook Incorporated
K070879	BARD MALECOT AND PEZZER DRAINS	Apr 24, 2007	Substantially Equivalent	C.R. Bard, Inc.
K981258	MANAN MALECOT BASKET DRAINAGE CATHETER	Apr 22, 1998	Substantially Equivalent	Medical Device Technologies, Inc.
K954147	MANAN MALECOT BASKET DRAINAGE CATHETER	Mar 26, 1996	Substantially Equivalent	Manan Medical Products, Inc.
K954116	SILICONE MALECOT CATHETER WITH PEZZER/MUSHROOM TIP	Nov 06, 1995	Substantially Equivalent	Technical Products, Inc.
K920423	OLYMPIC SMART SCALE CARE CENTER	Jun 11, 1992	Substantially Equivalent	Olympic Medical Corp.