Cleared Traditional

K936195 - LAPAROSCOPES

K936195 is the FDA 510(k) clearance for LAPAROSCOPES by Micromedical Devices, Inc.. It is a Class 2 General & Plastic Surgery device (product code GCJ) cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K936195 · Micromedical Devices, Inc. · General & Plastic Surgery device
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Aug 1994
Decision
231d
Days
Class 2
Risk

K936195 is an FDA 510(k) clearance for the LAPAROSCOPES. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Micromedical Devices, Inc. (Castle Pines Village, US). The FDA issued a Cleared decision on August 17, 1994 after a review of 231 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Micromedical Devices, Inc. devices

Submission Details

510(k) Number K936195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1993
Decision Date August 17, 1994
Days to Decision 231 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
116d slower than avg
Panel avg: 115d · This submission: 231d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GCJ Laparoscope, General & Plastic Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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 - GCJ Laparoscope, General & Plastic Surgery

All 708
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K936195.
CCD ENDOCAM OFFICE 5510
K942817 · Richard Wolf Medical Instruments Corp. · Aug 1994
ENDOPATH OPTICAL OBTURATOR AND SLEEVE
K941027 · Ethicon Endo-Surgery, Inc. · Aug 1994
SHARPLAN-CONTEC EC-1000 ENDOSCOPY VIDEO CAMERA SYSTEM
K942740 · Sharplan Lasers, Inc. · Aug 1994
KARL STORZ WOUND CLOSURE INSTRUMENTS
K942612 · KARL STORZ Endoscopy-America, Inc. · Aug 1994
OPSIS THORACOSCOPY VIDEO SYSTEM THORACICCAM AND THORACICCAM 360
K941950 · Baxter Healthcare Corp · Aug 1994
DISPOSABLE SURGICAL TROCAR
K943489 · Applied Medical Resources · Aug 1994