510(k) K880961 ยท LRO General Surgery Tray
ALCON SURGICAL PROCEDURE PACKS
| Applicant | Alcon Laboratories, Fort Worth TX, US |
| Decision | Substantially Equivalent, Apr 29, 1988 |
| Received | Mar 8, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K880961
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 6, 2025 | Alcon Research LLC Alcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17, 12698-09, 15632-10, 3141-45, 12630-07, 18925-05, 19265-05, 13894-16, 17550-08, 12236-18, 11854-15, 8043-29, 12466-17, 15599-1 Open, Classified |
LRO | None listed |
| Apr 22, 2024 | Alcon Research, LLC Various Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang Hydrodissection Cannulas. These Custom Paks are surgical procedure packs used by ophthalmic surgeons in a variety of opht Open, Classified |
LRO | None listed |
| Mar 22, 2024 | Alcon Research, LLC SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pak Surgical Procedure Packs, Products: 18018-06, 3865-44, 5675-76, 13554-11, 18018-06, 15190-16 , 15190-16, 15190-16, 15190 Open, Classified |
LRO | None listed |
| Nov 7, 2023 | Alcon Research, LLC Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR Open, Classified |
LRO | None listed |
| Mar 28, 2023 | Alcon Research, LLC Alcon Custom Pak Surgical Procedure Pack:
Pak Number & Pak Description:
17533-04 DR GROSS LPS LLC
18704-03 CATARACT SURGI CARE
18382-03 DR GEORGE ZAMBELLI BEAVER VALLEY ASC
8685-21 CATARACT PACK EYE S Open, Classified |
LRO | None listed |
| Dec 1, 2022 | Alcon Research, LLC Alcon Custom Pak Surgical Procedure Pack Open, Classified |
LRO | None listed |
| Jun 9, 2022 | Alcon Research, LLC Alcon Custom Pak Surgical Procedure Pack:
16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO SURGICAL HOSP
18392-03 14HDFF CATARACT SWAGEL WOOTTON EYE INSTITUTE
18527-03 14JM57 DOSS CATARACT ALLIANCE EYE Open, Classified |
LRO | None listed |
| Apr 1, 2021 | Alcon Research, LLC Alcon Custom Ophthalmic Surgical Procedure Packs Terminated |
LRO | None listed |
| Aug 24, 2020 | Alcon Research, LLC Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophthalmic surgeons in a variety of ophthalmic surgeries. Terminated |
LRO | None listed |
| Aug 25, 2017 | Alcon Research, LTD. Alcon Custom Pak Terminated |
LRO | None listed |
| Oct 30, 2015 | Alcon Research, Ltd. Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical procedure. Terminated |
LRO | None listed |
| Jun 9, 2015 | Alcon Research, Ltd. The Alcon Custom Pak. The Alcon Customer Pak is an assemblage of single-use medical devices and accessories designed by medical professionals for specific ophthalmic surgical procedures. Some Paks c Terminated |
LRO | None listed |
| Jun 30, 2014 | Alcon Research, Ltd. Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Number 585006 contained in Alcon Assembly Numbers 9795-37, 11233-14, and 13334-04.
The product is typically inserted through a Terminated |
LRO | None listed |
| May 26, 2009 | Alcon Laboratories, Inc Alcon Vitrectomy 25 GA Custom Pak, Catalog/Item #10240-03, 11077-03, 11187-02 and 13305-01; distributed by Alcon Laboratories, Inc., Fort Worth, TX 76134. Terminated |
NGY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.