Atlas FDA

ALCON SURGICAL PROCEDURE PACKS

FDA 510(k) clearance K880961 · decided 1988-04-29

Clearance details

K-number
K880961
Device name
ALCON SURGICAL PROCEDURE PACKS
Applicant
Alcon Laboratories
Decision
Substantially Equivalent
Date received
1988-03-08
Decision date
1988-04-29
Days to decision
52 days
Clearance type
Traditional
Product code
LRO
Device class
2
Regulation number
878.4370
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Fort Worth, TX, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Medline General Surgery Tray (K213481)Medline Industries, Inc.2022-05-24
Medline Cardiovascular Procedure Kit (K212258)Medline Industries, Inc.2021-12-03
SURGICAL DRAPE KIT - D.I.R.R.A. SRL (K041080)D.I.R.R.A. S.R.L.2004-11-30
QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE (K030721)Ballard Medical Products2003-03-31
AMSINO TRACHEOSTOMY CARE TRAY (K023276)Amsino International, Inc.2002-12-09
WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAY (K980137)Worldwide Medical Technologies, LLC1998-01-30
OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY (K971061)Opportunity, Inc.1997-06-11
OPPORTUNITY INC. GENERAL PURPOSE TRAY (K971062)Opportunity, Inc.1997-06-09
NEUROLOGICAL OR CRANI TRAYS (PACKS) (K932221)Associated Medical Products Co.1997-03-19
PRESBYTERIAN LINEN SERVICES SURGICAL PACKS (K970286)Medline Industries, Inc.1997-03-10
O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE (K965201)Trinity Laboratories, Inc.1997-02-14
RUNYON LARGE VOLUME PARACENTESIS KIT (K970187)Gi Supply1997-02-14

Recalls involving this device

RecordFirmDate
Alcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17, 12698-09, 15632 recall (Z-1293-2025)Alcon Research LLC2025-03-06
Various Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang Hydrodissect recall (Z-1606-2024)Alcon Research, LLC2024-04-22
SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pak Surgical Pr recall (Z-1370-2024)Alcon Research, LLC2024-03-22
Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA recall (Z-0260-2024)Alcon Research, LLC2023-11-07
Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS recall (Z-1291-2023)Alcon Research, LLC2023-03-28
Alcon Custom Pak Surgical Procedure Pack recall (Z-0354-2023)Alcon Research, LLC2022-12-01
Alcon Custom Ophthalmic Surgical Procedure Packs recall (Z-1328-2021)Alcon Research, LLC2021-04-01
Alcon Custom Pak recall (Z-0053-2018)Alcon Research, LTD.2017-08-25
Custom Pak 9319-27. Single-use medical devices and accessories designed by medical profess recall (Z-0195-2016)Alcon Research, Ltd.2015-10-30
The Alcon Custom Pak. The Alcon Customer Pak is an assemblage of single-use medical device recall (Z-1702-2015)Alcon Research, Ltd.2015-06-09
Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Number 585006 cont recall (Z-1947-2014)Alcon Research, Ltd.2014-06-30
Alcon Vitrectomy 25 GA Custom Pak, Catalog/Item #10240-03, 11077-03, 11187-02 and 13305-01 recall (Z-1644-2009)Alcon Laboratories, Inc2009-05-26

PMA approvals by this applicant

RecordFirmDate
VISCOAT™ Ophthalmic Viscosurgical Device; DUOVISC™ Ophthalmic Viscoelastic System; DISCOVISC™ Ophthalmic Viscosurgical D (P840064/S091)Alcon Laboratories2025-10-03
VISCOAT™ Ophthalmic Viscosurgical Device, DISCOVISC™ Ophthalmic Viscosurgical Device (P840064/S090)Alcon Laboratories2025-07-25
DISCOVISC Ophthalmic Viscosurgical Device (P840064/S088)Alcon Laboratories2025-02-26
VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC Ophthalmic Viscosurgical System (consists of PROVISC and VISCOAT), DIS (P840064/S086)Alcon Laboratories2024-08-12
PMMA Single-Piece Anterior Chamber IOL (P880087/S033)Alcon Laboratories2024-06-20
PMMA Multiple and Single-Piece Posterior Chamber IOLs (P840060/S051)Alcon Laboratories2024-06-20
PMMA Multiple and Single-Piece Posterior Chamber IOLs (P810032/S071)Alcon Laboratories2024-06-20
VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC™ Ophthalmic Viscosurgical System, DISCOVISC™ Ophthalmic Viscosurgical (P840064/S085)Alcon Laboratories2024-06-17