Cleared Traditional

FLEX-I-PORT (K940587) - FDA 510(k) Clearance

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

K940587 · Access Surgical Intl., Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
49d
Days
Class 2
Risk

K940587 is an FDA 510(k) clearance for the FLEX-I-PORT. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Access Surgical Intl., Inc. (Plymouth, US). The FDA issued a Cleared decision on March 29, 1994 after a review of 49 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 Access Surgical Intl., Inc. devices

Submission Details

510(k) Number K940587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1994
Decision Date March 29, 1994
Days to Decision 49 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
66d faster than avg
Panel avg: 115d · This submission: 49d
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 K940587.
AESCULAP TROCAR COLLAR
K941024 · Aesculap, Inc. · Apr 1994
MURDOCH LAPAROSCOPE LENS CLEANER
K941092 · Cook, Inc. · Apr 1994
AUTO SUTURE LAPAROSCOPIC FASCIA CLOSURE DEVICE II
K940398 · United States Surgical, A Division of Tyco Healthc · Apr 1994
KARL STORZ BIOP/BASK CUT/GRASP DISSEC/FLEX/CUT FORC
K934937 · KARL STORZ Endoscopy-America, Inc. · Mar 1994
AUTO SUTURE DISPOSABLE OPTICAL TROCAR
K935086 · United States Surgical, A Division of Tyco Healthc · Feb 1994
LAPAROSCOPIC TROCAR STARTER SCALPEL
K936154 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1994