Cleared Special

K070812 - DISPOSABLE LAPAROSCOPIC INSTRUMENT

K070812 is an FDA 510(k) clearance for DISPOSABLE LAPAROSCOPIC INSTRUMENT, manufactured by Modern Medical Equipment Mfg., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Special 510(k) pathway after a 172-day FDA review.

K070812 · Modern Medical Equipment Mfg., Ltd. · General & Plastic Surgery device
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Sep 2007
Decision
172d
Days
Class 2
Risk

K070812 is an FDA 510(k) clearance for the DISPOSABLE LAPAROSCOPIC INSTRUMENT. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Modern Medical Equipment Mfg., Ltd. (Richmond, US). The FDA issued a Cleared decision on September 14, 2007 after a review of 172 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Modern Medical Equipment Mfg., Ltd. devices

FDA 510(k) Submission Details - K070812

510(k) Number K070812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2007
Decision Date September 14, 2007
Days to Decision 172 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 115d · This submission: 172d
Pathway characteristics
Modification to existing cleared device.

GEI Device Classification - Class 2, Special Controls

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GEI Electrosurgical, Cutting & Coagulation & Accessories

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