510(k) K030179

MEDISISS PHACOEMULSIFICATION TIPS/NEEDLES by Surgical Instruments Service and Savings, Inc. — Product Code NKX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 24, 2003
Date Received: January 17, 2003
Clearance Type: Abbreviated
Expedited Review: No
Third Party Review: Yes

Device Classification

Device Name: Needle, Phacoemulsification, Reprocessed
Device Class: Class II
Regulation Number: 886.4670
Review Panel: OP
Submission Type

Needle for phacoemulsification device to remove cataractous lens. Same as needle for main phacoemulsification device and un-reprocessed needle with product code HQC, except this is a "reprocessed" needle. The Phacoemulsification device is NOT reprocessed, just the needle. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

Other clearances by Surgical Instruments Service and Savings, Inc.

K124033 — MEDISISS REPROCESSED ULTRASONIC INSTRUMENTS (January 7, 2014)
K031869 — SISS INC. (D.B.A. MEDISISS) REPROCESSED ELECTROSURGICAL INSTRUMENTS AND ACCESSOR (December 24, 2003)
K024011 — SISS REPROCESSED HOT BIOPSY FORCEPS, LAPAROSCOPIC, ENDOSCOPIC AND ELECTROSURGICA (December 19, 2002)
K012644 — REPROCESSED TROCARS AND CANNULAS (July 29, 2002)
K012669 — REPROCESSED ELECTROSURGICAL ELECTRODES (June 27, 2002)
K012667 — REPROCESSED ARTHROSCOPIC SHAPERS (June 3, 2002)
K012658 — REPROCESSED COMPRESSION LIMB SLEEVES (May 14, 2002)

510(k) K030179

Clearance Details

Device Classification

Other clearances by Surgical Instruments Service and Savings, Inc.

Other clearances for product code NKX