Cleared Traditional

K936154 - LAPAROSCOPIC TROCAR STARTER SCALPEL

K936154 is the FDA 510(k) clearance for LAPAROSCOPIC TROCAR STARTER SCALPEL by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 2 General & Plastic Surgery device (product code GCJ) cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K936154 · Bd Becton Dickinson Vacutainer Systems Preanalytic · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
39d
Days
Class 2
Risk

K936154 is an FDA 510(k) clearance for the LAPAROSCOPIC TROCAR STARTER SCALPEL. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on February 4, 1994 after a review of 39 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K936154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1993
Decision Date February 04, 1994
Days to Decision 39 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 115d · This submission: 39d
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 720
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K936154.
STERILE TROCAR AND 5.7MM SLEEVE
K940259 · Phx Technologies Corp. · Feb 1994
INNOVASIVE NON-STERILE LAPAROSCOPY INSTRUMENTS MODIFICATION
K934338 · Innovasive Devices, Inc. · Feb 1994
I SIGHT 2020 ENDOSCOPIC & SURGICAL VIDEO CAMERA
K934097 · Sharplan Lasers, Inc. · Feb 1994
BIOPSY CUP FORCEPS
K930180 · Surgical Technologies, Inc. · Feb 1994
FASCIAL CLOSURE DEVICE
K931522 · Origin Medsystems, Inc. · Feb 1994
LAPAROSCOPIC RETRACTOR
K933075 · Origin Medsystems, Inc. · Feb 1994