Cleared Traditional

LASSO (SCHWAITZBERG) SUTURE SNARE (K934737) - FDA 510(k) Clearance

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

K934737 · Performance Surgical Instruments Corp. · General & Plastic Surgery device
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Mar 1994
Decision
159d
Days
Class 2
Risk

K934737 is an FDA 510(k) clearance for the LASSO (SCHWAITZBERG) SUTURE SNARE. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Performance Surgical Instruments Corp. (South Easton, US). The FDA issued a Cleared decision on March 9, 1994 after a review of 159 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 Performance Surgical Instruments Corp. devices

Submission Details

510(k) Number K934737 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1993
Decision Date March 09, 1994
Days to Decision 159 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
44d slower than avg
Panel avg: 115d · This submission: 159d
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 399
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K934737.
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
SERIES 8920 TROCAR SYSTEM
K932441 · Richard Wolf Medical Instruments Corp. · Feb 1994