Cleared Traditional

K843264 - MONOJECT MENGHINI SOFT TISSUE BIOPSY

K843264 is an FDA 510(k) clearance for MONOJECT MENGHINI SOFT TISSUE BIOPSY, manufactured by Sherwood Medical Co.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K843264 · Sherwood Medical Co. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1984
Decision
119d
Days
Class 2
Risk

K843264 is an FDA 510(k) clearance for the MONOJECT MENGHINI SOFT TISSUE BIOPSY. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Sherwood Medical Co. (St. Louis, US). The FDA issued a Cleared decision on December 17, 1984 after a review of 119 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Sherwood Medical Co. devices

FDA 510(k) Submission Details - K843264

510(k) Number K843264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1984
Decision Date December 17, 1984
Days to Decision 119 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 129d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FMI Needle, Hypodermic, Single Lumen

All 457
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K843264.
JMS NEEDLES & JMS SYRINGES
K845043 · Jms Co., Ltd. · Apr 1985
CHURCHILL HABER POINT NEEDLE ADMIN. SET
K850420 · Churchill Corp. · Apr 1985
INFUSET W/HUBER NEEDLE
K844313 · Med Fusion Systems, Inc. · Jan 1985
AMER. PHARMASEAL CHEMONUCLEOLYSIS TRAY
K842542 · American Pharmaseal Div. Ahsc · Aug 1984
UMI CURVED CHEMONUCLEOLYSIS NEEDLE
K842012 · Universal Medical Instrument Corp. · Jul 1984
THINWALL PUNCTURE NEEDLE
K841704 · Meadox Surgimed, Inc. · Jun 1984