Cleared Traditional

K830673 - CRAFON ARTHROSCOPY LINES

K830673 is an FDA 510(k) clearance for CRAFON ARTHROSCOPY LINES, manufactured by Gambro, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K830673 · Gambro, Inc. · Orthopedic device
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Jun 1983
Decision
96d
Days
Class 2
Risk

K830673 is an FDA 510(k) clearance for the CRAFON ARTHROSCOPY LINES. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Gambro, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 8, 1983 after a review of 96 days - within the typical 510(k) review window.

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 Gambro, Inc. devices

FDA 510(k) Submission Details - K830673

510(k) Number K830673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1983
Decision Date June 08, 1983
Days to Decision 96 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
26d faster than avg
Panel avg: 122d · This submission: 96d
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 414
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K830673.
ACUFLEX LEVY ACL DRILL GUIDE SYS
K832277 · Acufex Microsurgical, Inc. · Aug 1983
ARTHROSCOPY INFUSION SYS..VALVE
K831218 · Acufex Microsurgical, Inc. · Jul 1983
PATELLAR FAT PAD RETRACTOR
K831248 · Techmedica, Inc. · Jun 1983
ESA ELECTROSURGICAL ARTHROSCOPY GENERA
K830499 · Concept, Inc. · Mar 1983
CRAFTON ARTHROSCOPY PUMP AP-10
K823848 · Gambro, Inc. · Mar 1983
ESA ARTHROSCOPY CANNULA TRAY
K823832 · Concept, Inc. · Feb 1983