Cleared Traditional

K843264 - MONOJECT MENGHINI SOFT TISSUE BIOPSY

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

K843264 · Sherwood Medical Co. · General Hospital
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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

Submission Details

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.

Device Classification

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 235
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K843264.
HEMED NEEDLE SUPPORT CATALOG NO. HAP-XXXX
K853731 · Gish Biomedical, Inc. · Oct 1985
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AMER. PHARMASEAL CHEMONUCLEOLYSIS TRAY
K842542 · American Pharmaseal Div. Ahsc · Aug 1984
OHIO HEAT REFLECTING PATCH
K840967 · Ohio Medical Products · Mar 1984
INTRADISCAL THERAPY TRAY
K834553 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1984