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) |
|---|---|---|---|
| Aug 29, 2014 | Customed, Inc LAPAROSCOPY COLORECTAL SURGICAL PACK
code 900-2259A, contains:
(1) SOLUTION SURGICAL DURAPREP 26ml LIF
(4) DRAPE UTILITY WITH TAPE LIF
(3) TOWELS ABSORBENT 15" X 20" LIF
(2) LEGGINS W/7'' CUFF 30" X Terminated |
FDE | None listed |
| Aug 29, 2014 | Customed, Inc Laparoscopy pack, , Code 900-3178, contains:
(1) BULB SYRINGE 60cc LIF
(10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF
(1) MAYO STAND COVER REINFORCED LIF
(1) TABLE COVER REINFORCED 50" X 90" LIF
(3) GOWN SUR Terminated |
FDE | None listed |
| Aug 29, 2014 | Customed, Inc LAP Abdom w/pouch Customed code 900-2619, contains:
(1) DRAPE LAP. ABDOM W/POUCH 102" X 122" X 78"
(1) WRAPPER 30" X 30"
Product Usage:
EO sterilized surgical convenient packs packaged into polyester Terminated |
FDE | None listed |
| Aug 29, 2014 | Customed, Inc TRANSVERSE LAPAROTOMY PACK (8)
CUSTOMED
CONTENT:
(1) TOWEL ABSORBENT 15" X 20"
(1) MAYO STAND COVER REINFORCED (4) DRAPE UTILITY WITHffAPE
(1) SUTURE BAG FLORAL
(1) DRAPE LAP TRANSVERSE
( Terminated |
FDE | None listed |
| Aug 29, 2014 | Customed, Inc LAPAROTOMY PACK 1 (2&3) CUSTOMED
CONTENT:
(2) TOWEL ABSORBENT 15" X 20"
(1) MAYO STAND COVER REINFORCED (4) DRAPE UTILITY WITHffAPE
(1) SUTURE BAG FLORAL
(1) DRAPE T LAPAROT 102" X 78" X 121 Terminated |
FDE | None listed |
| Aug 29, 2014 | Customed, Inc LAPAROSCOPY PACK I (4) CUSTOMED
CONTENTS:
(1) TOWEL ABSORBENT 15" X 20" LIF (2) LEGGINGS W/7'' CUFF 30" X 42" LIF (1) DRAPE UTILITY WITAPE L/F
(1) SUTURE BAG FLORAL LIF
(1) SHEET T LAPAROSCOPY Terminated |
FDE | None listed |
| Aug 29, 2014 | Customed, Inc LAPAROSCOPY ABO PACK (1) (2)
CUSTOMED
CONTENTS:
(1) GOWN SURG. REINFORCED X-LARGE TOWEL I WRAP (2) TOWELS ABSORBENT 15" X 20"
(2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED
(1) MAYO STAND COVER REI Terminated |
FDE | None listed |
| Aug 29, 2014 | Customed, Inc LAPAROSCOPY CHOLE SYSTEM PACK
MIAMI METRO
CON TENTS:
(12) TOWELS CLOTH HUCK BLUE LIF
(1) MAYO STAND COVER REINFORCED LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) SUTURE BAG FLORAL LIF
( Terminated |
FDE | None listed |
| Aug 29, 2014 | Customed, Inc LAPAROSCOPY COLORECTAL SURGICAL PACK
CONTENTS:
(1) SOLUTION SURGICAL DURAPREP 26ml LIF
(4) DRAPE UTILITY WITH TAPE LIF
(3) TOWELS ABSORBENT 15" X 20" LIF
(2) LEGGINS W/7'' CUFF 30" X 42" LI Terminated |
FDE | None listed |
| Aug 29, 2014 | Customed, Inc LAPAROSCOPIA COLORECTAL PACK
CONTENTS:
(1) SOLUTION SURGICAL DURAPREP 26ml
(4) DRAPE UTILITY WITH TAPE
(1) TOWELS ABSORBENT 15" X 20"
(2) LEGGINS W/7" CUFF 30" X 42"
(1) BLADE SURGICAL #15 S Terminated |
FDE | None listed |
| Aug 29, 2014 | Customed, Inc LAPAROSCOPY PACK
CONTENTS:
( I ) BULB SYRINGE 60cc LIF
( I 0) GAUZE SPONGE 4" X 4" 1 6PLY XRD LIF
( I ) MAYO STAND COYER REINFORCED LIF
( I ) TABLE COVER REINFORCED 50" X 90" LIF
(3) GOWN SU Terminated |
FDE | None listed |
| Aug 29, 2014 | Customed, Inc LAPAROSCOPY CHOLE PACK -
(6) TOWELS ABSORBENT 15" X 20" LIF
(1) MAYO STAND COVER REINFORCED L/F
(1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF
(1) SURGICAL BLADE #11 CARBON STEEL
(1) TUR Y SET, 2LEAD L Terminated |
FDE | None listed |
| Aug 29, 2014 | Customed, Inc LAPAROSCOPY PACK -
( 1) APPLIER MULTI CLIP WITH SHAF GUN L/F
( 1) NEEDLE ULTRA VERES 120MM LIF
( 1) TROCAR ENDOPATH XCEL DILATING TIP (K11LT) LIF
( 1) TROCAR ENDO.XCEL DILATING TIP (KSLT) LIF
(1) GOW Terminated |
FDE | None listed |
| Aug 29, 2014 | Customed, Inc LAPAROSCOPY PREMIUM PACK -
(1) TABLE COVER REINFORCED 50" x 90" UF
(4) TOWEL ABSORBENT 15" x 20" UF
(10) GAUZE SPONGE 4" X 4" 16PLY XRD UF
(1) DRAPE LASER CAMERA W/EL UF
(1) TROCAR ENDO.XCEL DILATING Terminated |
FDE | None listed |
| Aug 29, 2014 | Customed, Inc LAPAROSCOPY CHOLE PACK -
(1) DRAPE LASER CAMERA WITH ELASTIC 6" X 96" LIF
(2) SHEET DRAPE 42" X 57" SMS
(1) TUBE SUCTION CONNECT. %" X12' LIF
(1) SURGICAL BLADE #10 STAINLESS STEEL
(1) TABLE COVER RE Terminated |
FDE | None listed |
| Aug 29, 2014 | Customed, Inc D & C LAPAROSCOPY PACK -
(1) TUBING INSUFFLATION OPEN TIP WITHOUT VENT
(1) MAYO STAND COVER REINFORCED UF
(4) DRAPE UTILITY UF
(1) TRAY MAYO SMALL LIF
(1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL
(1) Terminated |
FDE | None listed |
| Aug 29, 2014 | Customed, Inc LAP AROSCOPY PACK -
(10) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF
(1) MAYO STAND COVER REINFORCED L/F
(4) ADHESIVE BANDAGE%" X 3" ST. LIF
(1) TABLE COVER REINFORCED 50" X 90" LIF
(2) GOWN IMPERVIOUS REINF Terminated |
FDE | None listed |
| Aug 29, 2014 | Customed, Inc LAPAROSCOPY CHOLE PACK -
(4) DRAPE UTILITY WITH TAPE LIF
(2) ABSORBENT TOWELS 15" X 20" LIF
(2) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE LIF
(1) SURGICAL DURAPREP SOLUTION 26ml LIF
(1) TUR Y SET 81 " Terminated |
FDE | None listed |
| Aug 29, 2014 | Customed, Inc LAPAROSCOPY GYN PACK -
(1) TABLE COVER REINFORCED 44" X 78"
(1) LAPAROSCOPY SHEET "T" SMS
(3) TOWELS ABSORBENT 15" X 20"
(1) SURGICAL BLADE#11 STAINLESS STEEL
(1) MAYO STAND COVER REINFORCED
(1) SYR Terminated |
FDE | None listed |
| Aug 29, 2014 | Customed, Inc LAPAROSCOPY GYN PACK - -
(1) BLADE SURGICAL #11 STAINLESS STEEL
(4) DRAPE UTILITY WITH TAPE LIF
(2) ABSORBENT TOWEL 15" X 20" LIF
(1) GOWN IMPERVIOUS REINFORCED LARGE SMS
(1) TOWEL CLOTH HUCK BLUE
( Terminated |
FDE | None listed |
| Aug 29, 2014 | Customed, Inc LAPAROSCOPY CHOLECYSTECTOMY SURGICAL PACK - -
(1) DRAPE LAPAROS/ABDOMINAL UF
(1) GOWN IMPER. EXTRA REINFORCED LGE TIVVRAP
(1) BLADE SURGICAL #11 STAINLESS STEEL
(1) TIME OUT BEACON NON WOVEN UF
Terminated |
FDE | None listed |
| Aug 29, 2014 | Customed, Inc LAPAROSCOPY CHOLECYSTECTOMY PACK -
(1) SHEET LAPAROS/ABDOMINAL UF
(1) MAYO STAND COVER REINFORCED UF
(1) BLADE SURGICAL #11 STAINLESS STEEL
(1) DRAPE SHEET 41 " X 58" SMS UF
(10) GAUZE SPONGE 4" X Terminated |
FDE | None listed |
| Aug 29, 2014 | Customed, Inc LAPAROSCOPY PACK - -
(1) MAYO STAND COVER REINFORCED LIF
(2) DRAPE % ECONOMY 53" X 77" LIF
(1) TUBE SUCTION CONNECT. v.i" X 12' LIF
(1) SCALPEL WITH HANDLE #11
(1) DRAPE LAP ABDOMINAL WITH POUCH 1 02 Terminated |
FDE | None listed |
| Aug 29, 2014 | Customed, Inc LAPAROSCOPY~OBPACK -
(4) ABSORBENT TOWELS 15" x 20" LIF
(2) LEGGINS WITH 7" CUFF
(1) LAPAROSCOPY T SHEET SMS
(1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF
(1) NEEDLE HYPODERMIC 18G X 1%
(1) *ROBIN RE Terminated |
FDE | None listed |
| Aug 29, 2014 | Customed, Inc LAPAROSCOPY PACK- -
(1) DRAPE LAP ABDOMINAL WITH POUCH
(1) CAMARA DRAPE 9" X 96" LIF
(5) TOWELS ABSORBENT 15" X 20"
(1) MAYO STAND COVER REINFORCED
(1) TABLE COVER REINFORCED 50" X 90"
(4) DRAPE UTIL Terminated |
FDE | None listed |
| Aug 29, 2014 | Customed, Inc LAPAROSCOPY CHOLE PACK - -
( 1) STRIP STERI CLOSURE W' X 4" LIF
( 1) TABLE COVER REINFORCED 50" X 90" LIF
( 1) DRAPE LAP ABDOMINAL W/POUCH 102" X 122" X 78" LIF
(2) GOWN LGE SMS IMPERVIOUS REINFORCED Terminated |
FDE | None listed |
| Aug 29, 2014 | Customed, Inc Customed Laparoscopy convenience pack include multiple components: gowns, table covers, needle and blade counter, bag suture, suture, sponges/gauzes, containers, syringes 20cc & 30cc w/o needle, need Terminated |
FDE | None listed |
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