Cleared Traditional

K963304 - STRYKER TEMPEST ORTHOPEDIC PUMP

K963304 is an FDA 510(k) clearance for STRYKER TEMPEST ORTHOPEDIC PUMP, manufactured by Stryker Endoscopy. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K963304 · Stryker Endoscopy · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
153d
Days
Class 2
Risk

K963304 is an FDA 510(k) clearance for the STRYKER TEMPEST ORTHOPEDIC PUMP. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Stryker Endoscopy (Santa Clara, US). The FDA issued a Cleared decision on January 22, 1997 after a review of 153 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.1100 - the FDA orthopedic device regulatory 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 Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Stryker Endoscopy devices

FDA 510(k) Submission Details - K963304

510(k) Number K963304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1996
Decision Date January 22, 1997
Days to Decision 153 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 122d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRX Device Classification - Class 2, Special Controls

Product Code HRX Arthroscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1100
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 Orthopedic devices follow this clearance model.

Regulatory Peers - HRX Arthroscope

All 415
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K963304.
VARIOUS ARTHROSCOPES, ENDOSCOPIC BLADES, MANUAL INSTRUMENTS
K971253 · Smith & Nephew, Inc. · Jun 1997
KARL STORZ MULTIDRIVE II MINI SHAVER FOR ARTHROSCOPY
K970055 · KARL STORZ Endoscopy-America, Inc. · Mar 1997
PNEUMATIC ARTHROSCOPY PULSED IRRIGATOR SYSTEM MODEL 0027030 AND BATTERY ARTHROSCOPY PULSED IRRIGATOR SYSTEM
K964879 · Davol Inc., Sub. C. R. Bard, Inc. · Mar 1997
KARL STORZ SLOTTED WHISKER ARTHROSCOPIC BLADE
K963029 · KARL STORZ Endoscopy-America, Inc. · Nov 1996
KSEA LARGE JOINT ARTHROSCOPY SET
K963524 · Karl Storz Endoscopy · Nov 1996
THERMO-PLASTIC SHAVER BLADES
K963332 · Stryker Endoscopy · Oct 1996