ClearanceBrief
Panels › Gastroenterology, Urology › Product code FDE · Class 2

Laparoscopy Kit

Regulation 876.1500

0510(k)s in 12 months (4 all time)
22recalls in 12 months (127 all time)
1recalls that name a 510(k)
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Top companies in FDE

DateFirm and productCodeLinked 510(k)
Oct 15, 2026Medline Industries, LP
Convenience Kits containing CONMED AirSeal Access Ports ADVANCE LAPAROSCOPIC DYNJ911135 LAP CHOLE DYNJ911660 LAP NISSEN DYNJ911560 UROLOGY LAPAROSCOPIC - 51638 DYNJ908720A
Open, Classified
FDENone listed
Oct 15, 2026Medline Industries, LP
Medline surgical convenience kits labeled as: 1) MAIN/LAPAROSCOPY TRANSPLA PACK, Medline product number/SKU DYNJ0656274AC; 2) MAIN/LAPAROSCOPY TRANSPLA PACK, Medline product number/SKU DYNJ0656274A
Open, Classified
FDENone listed
Oct 2, 2026GRI Medical & Electronic Technology Co., Ltd.
HALYARD Laparoscopy Comprehensive Pack II REF: 49332
Open, Classified
FDENone listed
Sep 25, 2026American Contract Systems Inc
Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ROBOTIC PACK - 242561 Model No. MHRB88AO
Open, Classified
FDENone listed
Sep 24, 2026Medline Industries, LP
Medline Convenience Kits: 1) MAJOR PACK, Catalog Number: DYNJ81325A
Open, Classified
FDENone listed
Sep 16, 2026Medline Industries, LP
Convenience kits MINOR PACK DYNJ58421A SPRINGHILL MINOR PACK DYNJ40734F
Open, Classified
FDENone listed
Sep 3, 2026Cardinal Health 200, LLC
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,GYN LAPAROSCOPY DH , Catalog Number: PBOCGLN17
Open, Classified
FDENone listed
Aug 31, 2026Medline Industries, LP
Medline Convenience Kits: 1) COLORECTAL ME, Model Number: DYNJ906437D
Open, Classified
FDENone listed
Aug 26, 2026Medline Industries, LP
Medline convenience kits labeled as: 1) MAJOR PROCEDURE, Medline Kit SKU CDS982040U; 2) OPERATIVE LAP P&S SURGICAL, Medline Kit SKU DYNJ89608; 3) LAPAROSCOPY, Medline Kit SKU DYNJ903479L; 4) LAPA
Open, Classified
FDENone listed
Jun 25, 2026Medline Industries, LP
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. BARIATRIC DYNJ905153J DYNJ905153K DYNJ905153L GYNE LAPAROTOMY PACK-LF DYNJ49593A LAPAROSCOPY DYNJ905157G DYNJ905
Open, Classified
FDENone listed
Jun 17, 2026Medline Industries, LP
MEDLINE Medical Procedure Kits labeled as: 1) CHEST EXPLORATION ECMO, Medline Kit Number/SKU DYNJ63789A; 2) CORONARY/ARTERY BYPASS TRAY, Medline Kit Number/SKU DYNJ17321G; 3) D&C/CYSTO, Medline Ki
Open, Classified
FDENone listed
Jun 12, 2026Medline Industries, LP
Medline convenience kits: ABD PACK DYNJ81673B BARIATRIC DYNJ902515K BARIATRIC + DYNJ904119O BARIATRIC CDS CDS983883J BWNBORO LAP CHOLE PACK-LF DYNJ32836B CCSB KARIN JWIRE LUMPECTOMY DYNJ910459B
Open, Classified
FDENone listed
May 7, 2026Medline Industries, LP
See RES for complete list. Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR LAPAROTOMY CDS, Model Number: CDS860015V; 3) MAJOR LAPAROTOMY CDS, Model Number: CDS860
Open, Classified
FDENone listed
Apr 30, 2026Medline Industries, LP
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. PLASTICS FREE FLAP, Medline Kit Number/SKU CDS983493N; 2. TLIF PACK, Medline Kit Number/SKU DYNJ02476O; 3.
Open, Classified
FDENone listed
Apr 17, 2026Medline Industries, LP
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BARIATRIC DYNJ905153M, DYNJ905153N GENERAL LAPAROSCOPY PACK DYNJ81602 LAPAROSCOPY DYNJ905157K, DYNJ905157L
Open, Classified
FDENone listed
Apr 17, 2026Medline Industries, LP
Medline Kits: 1) GENERAL LAPAROSCOPY, Model Number: CDS930027Y
Open, Classified
FDENone listed
Apr 7, 2026Medline Industries, LP
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. LAPAROSCOPIC HERNIORRHAPHY DSC, Medline SKU # DYNJ6
Open, Classified
FDENone listed
Feb 17, 2026Medline Industries, LP
Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR LAPAROTOMY CDS, Model Number: CDS860015V; 3) MAJOR LAPAROTOMY CDS, Model Number: CDS860015W; 4) MAJOR LAPAROTOM
Open, Classified
FDENone listed
Jan 28, 2026Medline Industries, LP
Medline medical procedure convenience kits labeled as: 1) SMJ LAP CHOLE PACK-LF, Kit SKU DYNJ19974P; 2) DEPAUL ABDOMINAL ENDOSCOPY-LF, Kit SKU DYNJ20027K; 3) LAPAROSCOPY PACK-LF, Kit SKU DYNJ20468
Open, Classified
FDENone listed
Jan 14, 2026Medline Industries, LP
Medline medical procedure convenience kits labeled as: 1) LAPAROSCOPY CDS-LF, REF CDS860235L; 2) GENERAL LAPAROSCOPIC, REF CDS930223M; 3) LAP CHOLE CDS, REF CDS983678K; 4) LAPAROSCOPY PELV CDS, R
Open, Classified
FDENone listed
Nov 14, 2025Medline Industries, LP
MEDLINE convenience kits labeled as: 1) MAJOR LAPAROTOMY CDS, REF CDS860015W; 2) MAJOR LAPAROTOMY CDS, REF CDS860015X; 3) MINOR LAPAROTOMY CDS, REF CDS860016R; 4) MINOR LAPAROTOMY CDS, REF CDS860
Open, Classified
FDENone listed
Nov 13, 2025Medline Industries, LP
DYNJ909119G ROBOTIC GASTRIC LAP SLEEVE-LF DYNJ909127F CYSTO DYNJ909129D GENERAL LAPAROSCOPY-LF
Open, Classified
FDENone listed
Oct 16, 2025American Contract Systems Inc.
Basic Biopsy Tray; Item Number/Description: AKRB26D ROBOTIC, AMGL09AA GENERAL LAPAROSCOPY, ANLC35AD LAP CHOLE PACK - 205956, ANLP25AJ LAPROSCOPY PACK - 205958, FYLA38E LAPCHOLAPPY PACK, IHDA88AH DIVIN
Open, Classified
FDENone listed
Aug 28, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: CDS984076J GYN ROBOTIC DYNJG001004A LAVH MINOR DYNJG901001B CRANIOTOMY DYNJ908819B KIT CRANIOTOMY (only units from SKU DYNJG
Open, Classified
FDENone listed
Aug 28, 2025American Contract Systems Inc
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAP CHOLE PACK, Model/Item Number CILC69L; 2) LAP CHOLE PACK, Model/Item Number HNLC80J; 3) LAP CHOLE PACK, Model/Item Nu
Open, Classified
FDENone listed
May 1, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits, labeled as: NON STERILE I&D KIT, REF DYKM1438
Open, Classified
FDENone listed
Apr 17, 2025MEDLINE INDUSTRIES, LP - Northfield
Refer to RES
Open, Classified
FDENone listed
Apr 4, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: TOL DR R PACK
Open, Classified
FDENone listed
Mar 25, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits labeled as: 1) ABLATION PACK, Pack Number DYNJ40629B; 2) ACH LAPAROSCOPIC GB PACK, Pack Number DYNJ67756A; 3) CHRISTUS WH LAP CHOLE PACK, Pack Number DYNJ60934B 4) CRMC LAP
Open, Classified
FDENone listed
Mar 21, 2025American Contract Systems, Inc.
Brand Name: Banner Health Systems Product Name: Lap Pack - 170307 Model/Catalog Number: BHLP62H Software Version: N/A Product Description: Convenience Kit Component: No
Open, Classified
FDENone listed
Mar 14, 2025MEDLINE INDUSTRIES, LP - Northfield
Proxima Drape labeled as MINOR PACK and LAPAROSCOPY. Sterile surgical drape.
Open, Classified
FDENone listed
Mar 14, 2025American Contract Systems Inc
LAPAROSCOPY PACK , Model No SFLA02A SFLA02B
Open, Classified
FDENone listed
Mar 14, 2025American Contract Systems Inc
LAPAROSCOPY PACK, Model Nos LLLA21J LLLA21J-02
Open, Classified
FDENone listed
Mar 14, 2025American Contract Systems Inc
LAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41G
Open, Classified
FDENone listed
Dec 30, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline custom medical procedure kits labeled as: 1) FREE FLAP BASIC SET-UP PK, REF DYNJ0991320J; 2) MVFF/FIBU #54-RF, REF DYNJ21927R; 3) FUNCTIONAL SINUS ENDOSCOPY, REF DYNJ40406A; 4) DR GOLDSTE
Open, Classified
FDENone listed
Dec 20, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline brand, medical procedure convenience kits, labeled as: 1) MVFF/FIBU #54-RF , SKU DYNJ21927R; 2) DIEP FLAP, SKU DYNJ910120A
Open, Classified
FDENone listed
Dec 5, 2024MEDLINE INDUSTRIES, LP - Northfield
MEDLINE convenience kits labeled as: 2) ABDOMINAL LAPAROSCOPY, REF CDS760057K; 3) ABDOMINAL LAPAROSCOPY, REF CDS760057L; 4) MAJOR LAPAROTOMY CDS, REF CDS860015W; 5) MINOR LAPAROTOMY CDS, REF CDS8
Open, Classified
FDENone listed
Nov 26, 2024MEDLINE INDUSTRIES, LP - Northfield
ENDO KIT, Medline Kit SKU DYKE1577A, Component Number 57469, 10 per case; Medline Convenience Kits containing Single Use Biopsy Valve MAJ-1555
Open, Classified
FDENone listed
Nov 5, 2024DeRoyal Industries Inc
DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06
Open, Classified
FDENone listed
Oct 23, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline brand medical procedure convenience kits, labeled as: 1) CYSTO CDS, REF CDS983525D; 2) CYSTO CDS, REF CDS983525D; 3) CYSTO PACK-LF, REF DYNJ25834B; 4) CYSTO PACK, REF DYNJ35569C; 5) PAVI
Open, Classified
FDENone listed
Oct 10, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ConMed/Unimax Detachable Endo Pocket
Open, Classified
FDENone listed
Sep 24, 2024American Contract Systems, Inc.
Essentia MAJ Laparotomy Std Pack, ESLT53B; Medical convenience kit
Open, Classified
FDENone listed
Sep 11, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) MINOR PROCEDURE, Pack Number CDS981509C; b) GENERAL LAPAROSCOPY CDS, Pack Number CDS981512J; c) OR MAJOR CDS, Pac
Open, Classified
FDENone listed
Sep 6, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits labeled as: 1) COMPREHENSIVE PROCEDURE PACK, Pack Number 7791 ; 2) LAVH CDS, Pack Number CDS760049AC; 3) LAPAROSCOPY CDS , Pack Number CDS760051AB; 4) LAPAROSCOPY CDS , P
Open, Classified
FDENone listed
Aug 28, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline procedural kits labeled as: 1) FETAL SURGERY-LF, Pack Number CDS840214Q; 2) FETAL SURGERY CDS-LF, Pack Number CMPJ26754O
Open, Classified
FDENone listed
Aug 22, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline medical procedure kits labeled as follows: a) CYSTO, REF DYNJ905000D; b) ENDO KIT, REF DYKE1462A; c) ENDOSCOPY KIT, REF DYKE1431B; d) ENDOSCOPY KIT, REF DYKE1623B; e) GENERAL LAPAROSCOPY
Open, Classified
FDENone listed
Aug 7, 2024American Contract Systems, Inc.
American Contract Systems Laparoscopy Litho Std Pack convenience kit and American Contract Systems Lap Chole convenience kit
Open, Classified
FDENone listed
Jun 28, 2024MEDLINE INDUSTRIES, LP - Northfield
Sterile surgical convenience kit: Medline Retrograde PK-22025203-LF, Pack #DYNJ47873L, containing a Pure Pouch with component Sterile Curved Kelly Hemostat, Reorder #66175.
Open, Classified
FDENone listed
Feb 25, 2024MEDLINE INDUSTRIES, LP - Northfield
MEDLINE Kits, trays, and packs labeled as follows: a) ASC GENERAL MINOR CDS, REF CDS983673G; b) ASC GENERAL MINOR CDS, REF CDS983673I; c) C NURSE BAG KIT, REF DYKM1425; d) DAILY DRIVELINE MGMT KI
Open, Classified
FDENone listed
Jan 26, 2024American Contract Systems, Inc.
Custom procedural convenience kits and trays, urological, labeled as: a) UROLOGY DAVINCI PACK, kit number HGUR87G; b) CYSTO PACK, kit number LVCY20; c) URO ROBOTIC PACK, kit number LVUR44;
Open, Classified
FDENone listed

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