Field-Lee Brain Biopsy Needle

Q: What is the product code of K801760?

The FDA product code is HAO – Instrument, Surgical, Non-Powered, a Class I (low risk) device regulated under 21 CFR 882.4535.

FDA 510(k) K801760 · American V. Mueller

Substantially Equivalent

510(k) numberK801760

Submission

Device name: Field-Lee Brain Biopsy Needle
Applicant: American V. Mueller
Mchenry, IL, US
Received: July 28, 1980
Decision date: September 9, 1980
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: HAO – Instrument, Surgical, Non-Powered
Device class: Class I (low risk)
Regulation: 21 CFR 882.4535
Specialty: Neurology

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More from Redmond Neurosurgical, Inc.

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K871685	Heyer-Schulte Spetzler Lumbar-Peritoneal Shunt SysJXG · Traditional	06/12/1987SE
K864676	Heyer-Schulte Hermetic External CSF Drain. SystemJXG · Traditional	12/29/1986SE
K862772	V. Mueller (R) Gooseneck Circular StaplerGAG · Traditional	08/18/1986SE
K861471	V. Mueller Vital Clip-Hemostatic ClipFZP · Traditional	06/06/1986SE
K854568	V. Mueller Pneumo-Intestinal 15 Vascular & 30 StapGEF · Traditional	12/02/1985SE
K854049	Heyer-Schulte Syringo Peritoneal ShuntJXG · Traditional	11/27/1985SE
K851082	V. Mueller Blom-Singer Esophageal Insufflation TesENW · Traditional	07/22/1985SE
K851974	V. Mueller Vital Skin StaplerGDT · Traditional	06/11/1985SE

Questions and answers

When was Field-Lee Brain Biopsy Needle cleared by the FDA?

Field-Lee Brain Biopsy Needle (K801760) received a 510(k) decision of Substantially Equivalent on September 9, 1980, 43 days after the submission was received.

What is the product code of K801760?

The FDA product code is HAO – Instrument, Surgical, Non-Powered, a Class I (low risk) device regulated under 21 CFR 882.4535.