Cleared Traditional

K951482 - ENDOSCOPES, FIBER OPTIC LAPAROSCOPES, (STERILIZABLE)

K951482 is an FDA 510(k) clearance for ENDOSCOPES, manufactured by Micro-Medical Devices, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K951482 · Micro-Medical Devices, Inc. · General & Plastic Surgery device
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Sep 1995
Decision
168d
Days
Class 2
Risk

K951482 is an FDA 510(k) clearance for the ENDOSCOPES, FIBER OPTIC LAPAROSCOPES, (STERILIZABLE). Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Micro-Medical Devices, Inc. (Castle Pines Village, US). The FDA issued a Cleared decision on September 14, 1995 after a review of 168 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 Micro-Medical Devices, Inc. devices

FDA 510(k) Submission Details - K951482

510(k) Number K951482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1995
Decision Date September 14, 1995
Days to Decision 168 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
53d slower than avg
Panel avg: 115d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCJ Device Classification - Class 2, Special Controls

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 1134
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K951482.
THE TULIP LARGE SOFT TISSUE RETRACTOR
K952980 · The Tulip Mfg. Co. · Sep 1995
THE TULIP J DISSECTOR
K952965 · The Tulip Mfg. Co. · Sep 1995
DEXIDE ENDO-LUBE KIT
K953611 · Dexide, Inc. · Sep 1995
FASCIA CLOSURE DEVICE
K954011 · KARL STORZ Endoscopy-America, Inc. · Sep 1995
IMAGYN ENDOSCOPE
K951996 · Imagyn Medical, Inc. · Sep 1995
IMAGYN ENDOSCOPE SHEATH
K951974 · Imagyn Medical, Inc. · Aug 1995