Cleared Traditional

K930667 - REUSABLE LAPAROSCOPIC INSTRUMENTS

K930667 is the FDA 510(k) clearance for REUSABLE LAPAROSCOPIC INSTRUMENTS by Snowden-Pencer. It is a Class 2 General & Plastic Surgery device (product code GCJ) cleared through the Traditional 510(k) pathway after a 461-day FDA review.

K930667 · Snowden-Pencer · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1994
Decision
461d
Days
Class 2
Risk

K930667 is an FDA 510(k) clearance for the REUSABLE LAPAROSCOPIC INSTRUMENTS. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Snowden-Pencer (Tucker, US). The FDA issued a Cleared decision on May 16, 1994 after a review of 461 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Snowden-Pencer devices

Submission Details

510(k) Number K930667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1993
Decision Date May 16, 1994
Days to Decision 461 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
346d slower than avg
Panel avg: 115d · This submission: 461d
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 694
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K930667.
SUTURE MANIPULATOR
K941286 · Richard Wolf Medical Instruments Corp. · May 1994
CORSON AND NEZHAT SUCTION/IRRIGATION PROBES
K935786 · Cabot Medical Corp. · May 1994
MALLEABLE BLUNT DISSECTOR INSTRUMENT, 5 MM
K940011 · Phx Technologies Corp. · May 1994
GORE LAPAROSCOPIC SUTURE PASSER
K935986 · W.L. Gore & Associates, Inc. · May 1994
SCISSORS FOR ENDOSCOPIC AND LAPAROSCOPIC PROCEDURES
K940346 · KARL STORZ Endoscopy-America, Inc. · May 1994
CONMED MODULAR DESIGN ELECTROSURGICAL LAPROSCOPY INSTRUMENTS
K934916 · Conmedcorp · May 1994