Cleared Traditional

MIST TROCARS (K951480) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K951480 · Mist, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
34d
Days
Class 2
Risk

K951480 is an FDA 510(k) clearance for the MIST TROCARS. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Mist, Inc. (Great Neck, US). The FDA issued a Cleared decision on May 3, 1995 after a review of 34 days - a notably fast clearance 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: 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 Mist, Inc. devices

Submission Details

510(k) Number K951480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1995
Decision Date May 03, 1995
Days to Decision 34 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 115d · This submission: 34d
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 354
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K951480.
KARL STORZ KOH NEEDLE HOLDERS, FORCEPS FOR SUTURING, SUTURE SCISSORS, TISSUE PROBES, INJECTION NEEDLE, IRRIGATION INSTRT
K951625 · KARL STORZ Endoscopy-America, Inc. · May 1995
IMPLANTABLE STAPLE
K950562 · United States Surgical, A Division of Tyco Healthc · May 1995
KARL STORZ ENDOSCOPES, TELESCOPE HOLDERS
K951535 · KARL STORZ Endoscopy-America, Inc. · May 1995
KARL STORZ PEDIATRIC PYLORIC SPREADER, PYLOROTOME, ENDOTOME
K951252 · KARL STORZ Endoscopy-America, Inc. · Apr 1995
KSEA STEINER ELECTROMECHANIC MORCELLATOR
K950339 · KARL STORZ Endoscopy-America, Inc. · Apr 1995
KARL STORZ PUNCTURE, INJECTION, ENDOSCOPIC, VERESS NEEDLE
K951251 · KARL STORZ Endoscopy-America, Inc. · Apr 1995