Cleared Traditional

ACCESS SURGICAL INT'L ENDOSCOPIC SURGICAL INSTRUM. (K922424) - FDA 510(k) Clearance

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

K922424 · Access Surgical Intl., Inc. · General & Plastic Surgery device
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Nov 1992
Decision
188d
Days
Class 2
Risk

K922424 is an FDA 510(k) clearance for the ACCESS SURGICAL INT'L ENDOSCOPIC SURGICAL INSTRUM.. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Access Surgical Intl., Inc. (Bedminster, US). The FDA issued a Cleared decision on November 25, 1992 after a review of 188 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 Access Surgical Intl., Inc. devices

Submission Details

510(k) Number K922424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1992
Decision Date November 25, 1992
Days to Decision 188 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
73d slower than avg
Panel avg: 115d · This submission: 188d
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 K922424.
ENDOPATH INTERCEED ABSORBABLE ADHESION BARRIER
K920595 · Ethicon, Inc. · Apr 1993
AESCULAP TROCAR INSTRUMENT SET
K922797 · Aesculap, Inc. · Mar 1993
AUTO SUTURE ENDOSCOPIC KNOT PUSHER
K925149 · United States Surgical, A Division of Tyco Healthc · Jan 1993
AUTO SUTURE ENDOSCOPIC MINI-RETRACTOR
K920068 · United States Surgical, A Division of Tyco Healthc · Sep 1992
AUTO SUTURE(R) ARTICULATING ENDOSCOPIC SCISSORS
K914752 · United States Surgical, A Division of Tyco Healthc · Jun 1992
LAP TISSUE COLLECTION BAG
K915286 · Baxter Healthcare Corp · Apr 1992