Cleared Traditional

K900610 - SHEPPERD CANNULA STILLETTE & OBDURATOR SET

K900610 is an FDA 510(k) clearance for SHEPPERD CANNULA STILLETTE & OBDURATOR SET, manufactured by Downs Surgical , Ltd.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K900610 · Downs Surgical , Ltd. · Orthopedic device
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Oct 1990
Decision
256d
Days
Class 2
Risk

K900610 is an FDA 510(k) clearance for the SHEPPERD CANNULA STILLETTE & OBDURATOR SET. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Downs Surgical , Ltd. (Sheffield S9 4wj, GB). The FDA issued a Cleared decision on October 22, 1990 after a review of 256 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 Downs Surgical , Ltd. devices

FDA 510(k) Submission Details - K900610

510(k) Number K900610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1990
Decision Date October 22, 1990
Days to Decision 256 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
134d slower than avg
Panel avg: 122d · This submission: 256d
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 393
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K900610.
POWERCUT SURGICAL SYSTEM, BLADES, AND ACCESSORIES
K904720 · Baxter Healthcare Corp · Oct 1990
SHEPPERD LUMBAR DISCECTOMY SYSTEM
K900608 · Downs Surgical , Ltd. · Oct 1990
SHEPPERD STRAIGHT AND CURVED NEEDLES
K900609 · Downs Surgical , Ltd. · Oct 1990
SHEPPERD DILATATION TUBE SET (GS-501-20-H)
K900611 · Downs Surgical , Ltd. · Oct 1990
SHEPPERD TREPHINE SET (GS-501-30-V)
K900612 · Downs Surgical , Ltd. · Oct 1990
SHEPPERD SHELTER TUBE COMPLETE & DRILL
K900613 · Downs Surgical , Ltd. · Oct 1990