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)
Top companies in FDE
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2026 | Medline Industries, LP Convenience Kits containing CONMED AirSeal Access Ports
ADVANCE LAPAROSCOPIC
DYNJ911135
LAP CHOLE
DYNJ911660
LAP NISSEN
DYNJ911560
UROLOGY LAPAROSCOPIC - 51638
DYNJ908720A Open, Classified |
FDE | None listed |
| Oct 15, 2026 | Medline 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 |
FDE | None listed |
| Oct 2, 2026 | GRI Medical & Electronic Technology Co., Ltd. HALYARD Laparoscopy Comprehensive Pack II
REF: 49332 Open, Classified |
FDE | None listed |
| Sep 25, 2026 | American Contract Systems Inc Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays
ROBOTIC PACK - 242561
Model No. MHRB88AO Open, Classified |
FDE | None listed |
| Sep 24, 2026 | Medline Industries, LP Medline Convenience Kits:
1) MAJOR PACK, Catalog Number: DYNJ81325A Open, Classified |
FDE | None listed |
| Sep 16, 2026 | Medline Industries, LP Convenience kits
MINOR PACK
DYNJ58421A
SPRINGHILL MINOR PACK
DYNJ40734F Open, Classified |
FDE | None listed |
| Sep 3, 2026 | Cardinal Health 200, LLC Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:
1) KIT,GYN LAPAROSCOPY DH , Catalog Number: PBOCGLN17 Open, Classified |
FDE | None listed |
| Aug 31, 2026 | Medline Industries, LP Medline Convenience Kits:
1) COLORECTAL ME, Model Number: DYNJ906437D Open, Classified |
FDE | None listed |
| Aug 26, 2026 | Medline 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 |
FDE | None listed |
| Jun 25, 2026 | Medline 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 |
FDE | None listed |
| Jun 17, 2026 | Medline 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 |
FDE | None listed |
| Jun 12, 2026 | Medline 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 |
FDE | None listed |
| May 7, 2026 | Medline 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 |
FDE | None listed |
| Apr 30, 2026 | Medline 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 |
FDE | None listed |
| Apr 17, 2026 | Medline 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 |
FDE | None listed |
| Apr 17, 2026 | Medline Industries, LP Medline Kits:
1) GENERAL LAPAROSCOPY, Model Number: CDS930027Y Open, Classified |
FDE | None listed |
| Apr 7, 2026 | Medline 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 |
FDE | None listed |
| Feb 17, 2026 | Medline 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 |
FDE | None listed |
| Jan 28, 2026 | Medline 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 |
FDE | None listed |
| Jan 14, 2026 | Medline 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 |
FDE | None listed |
| Nov 14, 2025 | Medline 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 |
FDE | None listed |
| Nov 13, 2025 | Medline Industries, LP DYNJ909119G ROBOTIC GASTRIC LAP SLEEVE-LF
DYNJ909127F CYSTO
DYNJ909129D GENERAL LAPAROSCOPY-LF Open, Classified |
FDE | None listed |
| Oct 16, 2025 | American 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 |
FDE | None listed |
| Aug 28, 2025 | MEDLINE 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 |
FDE | None listed |
| Aug 28, 2025 | American 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 |
FDE | None listed |
| May 1, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline procedure kits, labeled as: NON STERILE I&D KIT, REF DYKM1438 Open, Classified |
FDE | None listed |
| Apr 17, 2025 | MEDLINE INDUSTRIES, LP - Northfield Refer to RES Open, Classified |
FDE | None listed |
| Apr 4, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows:
TOL DR R PACK Open, Classified |
FDE | None listed |
| Mar 25, 2025 | MEDLINE 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 |
FDE | None listed |
| Mar 21, 2025 | American 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 |
FDE | None listed |
| Mar 14, 2025 | MEDLINE INDUSTRIES, LP - Northfield Proxima Drape labeled as MINOR PACK and LAPAROSCOPY. Sterile surgical drape. Open, Classified |
FDE | None listed |
| Mar 14, 2025 | American Contract Systems Inc LAPAROSCOPY PACK
, Model No SFLA02A
SFLA02B Open, Classified |
FDE | None listed |
| Mar 14, 2025 | American Contract Systems Inc LAPAROSCOPY PACK, Model Nos LLLA21J
LLLA21J-02 Open, Classified |
FDE | None listed |
| Mar 14, 2025 | American Contract Systems Inc LAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41G Open, Classified |
FDE | None listed |
| Dec 30, 2024 | MEDLINE 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 |
FDE | None listed |
| Dec 20, 2024 | MEDLINE 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 |
FDE | None listed |
| Dec 5, 2024 | MEDLINE 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 |
FDE | None listed |
| Nov 26, 2024 | MEDLINE 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 |
FDE | None listed |
| Nov 5, 2024 | DeRoyal Industries Inc DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06 Open, Classified |
FDE | None listed |
| Oct 23, 2024 | MEDLINE 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 |
FDE | None listed |
| Oct 10, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ConMed/Unimax Detachable Endo Pocket Open, Classified |
FDE | None listed |
| Sep 24, 2024 | American Contract Systems, Inc. Essentia MAJ Laparotomy Std Pack, ESLT53B; Medical convenience kit Open, Classified |
FDE | None listed |
| Sep 11, 2024 | MEDLINE 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 |
FDE | None listed |
| Sep 6, 2024 | MEDLINE 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 |
FDE | None listed |
| Aug 28, 2024 | MEDLINE 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 |
FDE | None listed |
| Aug 22, 2024 | MEDLINE 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 |
FDE | None listed |
| Aug 7, 2024 | American Contract Systems, Inc. American Contract Systems Laparoscopy Litho Std Pack convenience kit and American Contract Systems Lap Chole convenience kit Open, Classified |
FDE | None listed |
| Jun 28, 2024 | MEDLINE 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 |
FDE | None listed |
| Feb 25, 2024 | MEDLINE 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 |
FDE | None listed |
| Jan 26, 2024 | American 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 |
FDE | None listed |
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