ClearanceBrief
Panels › Obstetrics/Gynecology › Product code OJF · Class 2

Hysterectomy Kit

Regulation 884.4530

0510(k)s in 12 months (0 all time)
15recalls in 12 months (30 all time)
0recalls that name a 510(k)
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Top companies in OJF

DateFirm and productCodeLinked 510(k)
Oct 15, 2026Medline Industries, LP
Convenience Kits containing CONMED AirSeal Access Ports ADVANCE LAPAROSCOPIC DYNJ911135A CHN GYN ONCOLOGY DYNJ906731M
Open, Classified
OJFNone listed
Sep 25, 2026Cardinal Health 200, LLC
Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAVH , Catalog Number: PB63VHSTC
Open, Classified
OJFNone listed
Sep 25, 2026American Contract Systems Inc
Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ABDOMINAL HYSTERECTOMY - 205989 Model No. MHAH55AM LAVH-LAP COLON Model No. SPLL54U VAG HYST
Open, Classified
OJFNone listed
Sep 3, 2026Cardinal Health 200, LLC
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) PBCGLVBLI, Catalog Number: KIT, BLO LAVH ; 2) PB15HYFCY, Catalog Number: KIT, UMMC AB HYST II
Open, Classified
OJFNone listed
Aug 26, 2026Medline Industries, LP
Medline convenience kits labeled as: 1) LAVH, Medline Kit SKU CDS982273U; 2) GYN ABDOMINAL CDS, Medline Kit SKU CDS982654L; 3) GYN LAP HYSTERECTOMY CDS, Medline Kit SKU CDS982662Q; 4) CMH VAG HYS
Open, Classified
OJFNone listed
Jun 17, 2026Medline Industries, LP
MEDLINE Medical Procedure Kits labeled as CLOVIS HYSTEROSCOPY, CSC-N PELVISCOPY, D AND C PACK, D&C HYSTER PACK, FLWR GYN PACK, FS LAP TUBAL LIGATION, HILLSDALE D&C / HYSTEROSCOPY, LAVH NEW BRAUNFELS,T
Open, Classified
OJFNone listed
Jun 12, 2026Medline Industries, LP
Medline convenience kits: HYSTERECTOMY PACK-LF DYNJ20485L
Open, Classified
OJFNone listed
Jun 12, 2026Medline Industries, LP
Medline convenience kits: WT LAVH PACK DYNJ46609F
Open, Classified
OJFNone listed
May 7, 2026Medline Industries, LP
Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91A; 3) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807J; 4) VAGINAL HYST
Open, Classified
OJFNone listed
Apr 30, 2026Medline Industries, LP
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269B; 2. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DY
Open, Classified
OJFNone listed
Apr 17, 2026Medline Industries, LP
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ENSEMBLE GYNECO SCOPIE-LF DYNJ53744B LAVH GRH-LF DYNJ41792G
Open, Classified
OJFNone listed
Apr 17, 2026Medline Industries, LP
Medline Kits: 1) HYSTEROSCOPY PACK, Model Number: DYNJ48399C; 2) SLING PACK, Model Number: DYNJ62849B
Open, Classified
OJFNone listed
Feb 17, 2026Medline Industries, LP
Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91A; 3) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807J; 4) VAGINAL HYST
Open, Classified
OJFNone listed
Jan 14, 2026Medline Industries, LP
Medline medical procedure convenience kits labeled as: 1) LAVH PROCEDURE, REF CDS980754T; 2) GYN LAP HYSTERECTOMY CDS, REF CDS982662Q; 3) DAVINCI HYSTERECTOMY CDS, REF CDS985344F; 4) LAVH, REF DY
Open, Classified
OJFNone listed
Nov 14, 2025Medline Industries, LP
MEDLINE convenience kits labeled as: 1) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F; 2) MAJOR LITHOTOMY PACK-LF, REF DYNJ0425778O; 3) MINOR VAGINAL #76-RF, REF DYNJ27434R; 4) ABDOMINAL HYST P
Open, Classified
OJFNone listed
Aug 28, 2025American Contract Systems Inc
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ROBOT HYST PACK, MODEL/ITEM NUMBER GRRB10E; 2) VAG HYST PACK, MODEL/ITEM NUMBER SPVH62P.
Open, Classified
OJFNone listed
Apr 17, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits used for various procedures: 1) PERI GYN PACK, Model Number: DYNJ80786; 2) D & C HYSTEROSCOPY PACK, Model Number: DYNJ21937J; 3) VAGINAL HYSTERECTOMY WRH-LF, Model Number: D
Open, Classified
OJFNone listed
Mar 25, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits labeled as: 1) CSMC/ABDOMINAL HYST PACK-LF, Pack Number DYNJ0665086F; 2) MAJOR VAGINAL HARPER PACK-LF, Pack Number DYNJ0161768D; 3) ROBOT LAP TOTAL HYST, Pack Number DYNJ907
Open, Classified
OJFNone listed
Feb 10, 2025Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFA; 2) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFB 3) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFC
Open, Classified
OJFNone listed
Dec 5, 2024MEDLINE INDUSTRIES, LP - Northfield
MEDLINE convenience kits labeled as: 1) MAJOR LITHOTOMY CDS-LF, REF CDS760056G; 2) LAVH CDS, REF CDS983411J; 3) MAJOR VAGINAL, REF CDS983497L; 4) DAY SURG LARGE VAG CDS, REF CDS984995N; 5) GYN L
Open, Classified
OJFNone listed
Oct 23, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline brand medical procedure convenience kits, labeled as: a) ABDOMINAL HYSTERECTOMY TEGH-LF, REF DYNJ46730; b) HYSTEROSCOPY PACK, REF DYNJ49302A; c) PERI GYN PACK, REF DYNJ57526A; d) HYSTEROS
Open, Classified
OJFNone listed
Sep 6, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits labeled as: 1) OFFICE PACK FOR HYSTEROSCOPY, Pack Number C040100; 2) LAVH CDS, Pack Number CDS760049AD; 3) LAVH CDS, Pack Number CDS760049AF; 4) MAJOR LITHOTOMY CDS-LF, P
Open, Classified
OJFNone listed
Aug 28, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline procedural kits labeled as: 1) LEEP PACK, Pack Number DYNJ40348G; 2) TRAB BUCKLE DSC, Pack Number DYNJ63036B
Open, Classified
OJFNone listed
Jan 26, 2024American Contract Systems, Inc.
Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LavH, kit number BBLV21C; b) LAP HYST 247540, kit number BFHY75U
Open, Classified
OJFNone listed
Oct 26, 2023American Contract Systems, Inc.
LAVH, REF BBLV21C
Open, Classified
OJFNone listed
Aug 3, 2023MEDLINE INDUSTRIES, LP - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CUSTOM GYN, Model Number: DYNJ63257C; b. GYN EXP LAPAROTOMY, Model Number: DYNJ906
Open, Classified
OJFNone listed
Jul 20, 2023MEDLINE INDUSTRIES, LP - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VNUS TRAY, Model Number DYNJ44410G; b) INTRAUTERINE TRNSFUSION -LF, Model Number DYNJ9048708I; c) PERI NEURO
Open, Classified
OJFNone listed
Feb 6, 2023MEDLINE INDUSTRIES, LP - Northfield
Sterile Procedural Trays, labeled as the following: a. GYN ABD CDS b. LAVH PROCEDURE c. TAH CDS d. CUH LITHOTOMY CDS e. LAVH CDS f. GROTH VAGINAL CDS g. MAJOR LITHOTOMY h. MAJOR VAGINAL HARPER PACK
Open, Classified
OJFNone listed
Dec 16, 2014Customed, Inc
Total Hysterectomy, catalog #900-2415 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
OJFNone listed
Aug 29, 2014Customed, Inc
TOTAL HYCTERECTOMY (I) CANNULA 5MM XCEL SLEEVES LIF ( I ) TROCAR XCEL BLADELESS II MM (I) TROCAR 5MM BLADELESS W/STAB SLEEVE LIF ( I) NEEDLE ULTRA VERES 120MM LIF ( I) TUBING INSUFFLAT SET
Terminated
OJFNone listed

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