Cleared Traditional

MANUAL SURGICAL INSTRUMENT FOR GENERAL USE (K950198) - FDA 510(k) Clearance

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

K950198 · United States Surgical, A Division of Tyco Healthc · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
22d
Days
Class 2
Risk

K950198 is an FDA 510(k) clearance for the MANUAL SURGICAL INSTRUMENT FOR GENERAL USE. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on February 9, 1995 after a review of 22 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 United States Surgical, A Division of Tyco Healthc devices

Submission Details

510(k) Number K950198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1995
Decision Date February 09, 1995
Days to Decision 22 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
93d faster than avg
Panel avg: 115d · This submission: 22d
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 393
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K950198.
MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
K950503 · United States Surgical, A Division of Tyco Healthc · Feb 1995
KARL STORZ TAKE-APART(R) SUTURE FORCEPS, KARL STORZ KNOT TIER
K945890 · KARL STORZ Endoscopy-America, Inc. · Feb 1995
KARL STORZ ADAPTERS FOR DOCUMENTATION PURPOSES
K950336 · KARL STORZ Endoscopy-America, Inc. · Feb 1995
KARL STORTZ PIVOT ARM LAPAROSCOPE SLEEVE, ENDO-RETRACTOR
K946330 · KARL STORZ Endoscopy-America, Inc. · Feb 1995
LAPAROSCOPE AND ACCESSORIES FOR GENERAL SURGERY
K950231 · Olympus America, Inc. · Feb 1995
MINI LAPAROSCOPY FOR GENERAL SURGERY
K950278 · Olympus America, Inc. · Feb 1995