Cleared Traditional

K940684 - SURGICAL INSTRUMENT, DISPOSABLE

K940684 is an FDA 510(k) clearance for SURGICAL INSTRUMENT, manufactured by Her-Mar, Inc.. The device is a Class 1 General & Plastic Surgery device with product code MDM cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K940684 · Her-Mar, Inc. · General & Plastic Surgery device
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Mar 1994
Decision
32d
Days
Class 1
Risk

K940684 is an FDA 510(k) clearance for the SURGICAL INSTRUMENT, DISPOSABLE. Classified as Instrument, Manual, Surgical, General Use (product code MDM), Class I - General Controls.

Submitted by Her-Mar, Inc. (Miami Beach, US). The FDA issued a Cleared decision on March 14, 1994 after a review of 32 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Her-Mar, Inc. devices

FDA 510(k) Submission Details - K940684

510(k) Number K940684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1994
Decision Date March 14, 1994
Days to Decision 32 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 115d · This submission: 32d
Pathway characteristics
Predicate-based equivalence.

MDM Device Classification - Class 1, General Controls

Product Code MDM Instrument, Manual, Surgical, General Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - MDM Instrument, Manual, Surgical, General Use

All 15
Devices cleared under the same product code (MDM) and FDA review panel - the closest regulatory comparables to K940684.
SAPHLIFT
K990062 · Genzyme Surgical Product (Genzyme Biosurgery) · Mar 1999
ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG
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K942896 · Surgin Surgical Instrumentation, Inc. · Jul 1994
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K930399 · O.R. Concepts, Inc. · Feb 1993
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K921988 · Cypress Medical Products, Ltd. · Nov 1992
QUALTEX LIGHT HANDLE AND LIGHT HANDLE COVER
K911369 · Deroyal Industries, Inc. · May 1991