Cleared Traditional

K001765 - LOOK COLLAGEN SPACERS

K001765 is an FDA 510(k) clearance for LOOK COLLAGEN SPACERS, manufactured by Surgical Specialties Corp. The device is a Class 2 Radiology device with product code KXK cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K001765 · Surgical Specialties Corp · Radiology device
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Sep 2000
Decision
87d
Days
Class 2
Risk

K001765 is an FDA 510(k) clearance for the LOOK COLLAGEN SPACERS, MODEL 1514B. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Surgical Specialties Corp (Reading, US). The FDA issued a Cleared decision on September 7, 2000 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5730 - the FDA radiology and imaging software oversight 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 Surgical Specialties Corp devices

FDA 510(k) Submission Details - K001765

510(k) Number K001765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2000
Decision Date September 07, 2000
Days to Decision 87 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 107d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KXK Device Classification - Class 2, Special Controls

Product Code KXK Source, Brachytherapy, Radionuclide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5730
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 Radiology devices follow this clearance model.

Regulatory Peers - KXK Source, Brachytherapy, Radionuclide

All 32
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K001765.
MODIFICATION TO ACCU-SPACE PLAIN GUT ABSORBABLE SEEDING SPACERS
K013964 · Cp Medical · Jan 2002
ACCU-SPACE ABSORBABLE SEEDING SPACERS
K010621 · Cp Medical · Sep 2001
SELECT SEED I-125
K002429 · Nucletron Corp. · Feb 2001
RADIONUCLIDE CATHETERS, RNC-A, RNC-G, RNC-U
K923697 · Radionics, Inc. · Dec 1993
MANAN PROSTATE SEEDING NEEDLE
K902622 · Manan Medical Products, Inc. · Aug 1990
CESIUM 137 ENDOMETRIAL SOURCE
K850433 · Syncor Intl. Corp. · Aug 1985