Cleared Traditional

K963648 - STRYKER SUCTION REGULATOR

K963648 is the FDA 510(k) clearance for STRYKER SUCTION REGULATOR by Stryker Endoscopy. It is a Class 2 General Hospital device (product code GCX) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K963648 · Stryker Endoscopy · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
75d
Days
Class 2
Risk

K963648 is an FDA 510(k) clearance for the STRYKER SUCTION REGULATOR. Classified as Apparatus, Suction, Operating-room, Wall Vacuum Powered (product code GCX), Class II - Special Controls.

Submitted by Stryker Endoscopy (Santa Clara, US). The FDA issued a Cleared decision on November 26, 1996 after a review of 75 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6740 - the FDA general hospital 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 Stryker Endoscopy devices

Submission Details

510(k) Number K963648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1996
Decision Date November 26, 1996
Days to Decision 75 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 129d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GCX Apparatus, Suction, Operating-room, Wall Vacuum Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6740
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 Hospital devices follow this clearance model.

Regulatory Peers - GCX Apparatus, Suction, Operating-room, Wall Vacuum Powered

All 39
Devices cleared under the same product code (GCX) and FDA review panel - the closest regulatory comparables to K963648.
SUCTION INSTRUMENTATION
K972074 · Walter Lorenz Surgical, Inc. · Jul 1997
MEDI-VAC FLEXI-CLEAR SUCTION HANDLE
K964127 · Allegiance Healthcare Corp. · Dec 1996
CURITY THORACENTESIS TRAY
K964519 · Kendall Healthcare Products Co. Div.Of Tyco Health · Dec 1996
STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION)
K954726 · Stryker Endoscopy · Nov 1995
PLEUR-EVAC(R) ADULT/PEDI DUAL COLL CHEST DRAIN SYS
K924337 · Deknatel, Inc. · Jul 1993
COOPERSURGICAL MODEL 6080 SMOKE EVACUATOR SYSTEM
K910377 · CooperSurgical, Inc. · Apr 1991