Cleared Traditional

K954052 - ARTHROSCOPIC GRASPER, CUP FORCEPS AND CURETTES
(FDA 510(k) Clearance)

K954052 · T. Korossurgical Instruments Corp. · Orthopedic

Nov 1995

Decision

69d

Days

Class 2

Risk

K954052 is an FDA 510(k) clearance for the ARTHROSCOPIC GRASPER, CUP FORCEPS AND CURETTES. This device is classified as a Arthroscope (Class II — Special Controls, product code HRX).

Submitted by T. Korossurgical Instruments Corp. (Moorepark, US). The FDA issued a Cleared decision on November 6, 1995, 69 days after receiving the submission on August 29, 1995.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.1100. 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)..

Submission Details

510(k) Number	K954052 FDA.gov
FDA Decision	Cleared SN
Date Received	August 29, 1995
Decision Date	November 06, 1995
Days to Decision	69 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—

Device Classification

Product Code	HRX — Arthroscope
Device Class	Class II — 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).