# K030179: Medisiss Phacoemulsification Tips/Needles

- Pathway: 510(k) (Abbreviated)
- Applicant: Surgical Instruments Service and Savings, Inc.
- Decided: Jan 24, 2003 after 7 days
- Product code: NKX (Needle, Phacoemulsification, Reprocessed)
- Device class: 2
- Regulation: 21 CFR 886.4670
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K902798 (1990). 12 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981103: Turbosonics Limited Reuse Ultrasonic Tip, Alcon Laboratories (1998) Summary page 5.
- K861380: Series Ten Thousand Master, CooperVision, Inc. (1986) Summary page 5.
- K902798: Automated Hydrosonics (TM), Alcon Surgical, Inc. (1990) Summary page 5.
- K911808: Gemini Ophthalmic Surgery System, Alcon Laboratories (1991) Summary page 5.
- K980292: Cataract Liquefracture Device, Alcon Laboratories (1998) Summary page 5.

## Cited in the summary but kept off the family tree
- K832836: Basal Med. #B9763 W/Hanks Salts W/L-G, Sigma Chemical Co. (1983). Our reading of the summary gave K832836, FDA’s number for Basal Med. #B9763 W/Hanks Salts W/L-G (Sigma Chemical Co.). Its FDA name has none of the distinctive words the summary uses for the device it names, “ALCON Phacoemulsification Tips/Needles”. Kept off the family tree. Summary page 5.

## Most influential descendants
- K041841: Pachycam (2005), 3 descendants of its own
- K073508: Parkone (2008), 1 descendant of its own
- K202989: Myopia Master (2021), 0 descendants of its own
- K113066: Corvis ST (2012), 0 descendants of its own

## Recalls of this device
- May 3, 2013 · Class II · Z-1642-2013: The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

## Indications for use
The MediSISS™ Reprocessed Phacoemulsification Tips/Needles are intended to emulsify and excise cataract tissue in ophthalmic microsurgical procedures.

Source page: https://510kreport.com/device/K030179
Methodology: https://510kreport.com/methodology