ClearanceBrief
Panels › General, Plastic Surgery › Product code GBW · Class 1

Catheter, Peritoneal

Regulation 878.4200

0510(k)s in 12 months (17 all time)
1recalls in 12 months (15 all time)
13recalls that name a 510(k)
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Top companies in GBW

Company510(k)sRecalls
ConMed Corporation06
Sil-Med Corp.40
Taut, Inc.31
ARROW INTERNATIONAL, LLC03
Boston Scientific Corp03
Teleflex Medical02
A.D.T. Lab Industries10
Arrow Intl., Inc.10
Core Dynamics, Inc.10
Helix Medical, Inc.10
DateFirm and productCodeLinked 510(k)
Jun 13, 2026ARROW INTERNATIONAL, LLC
Description/REF: PERITONEAL LAVAGE CATH KIT:8FR/AK-09000
Open, Classified		 GBWK811627
Dec 12, 2017Boston Scientific Corporation
Malecot Nephrostomy Catheter System, Product Number: M001224110, GTIN: 08714729030980 The Malecot and the Stenting Malecot Catheters are designed for percutaneous drainage within the renal collectin
Terminated		 GBWK811378
Jun 27, 2016ConMed Corporation
CORE Trumpet Handpiece only, Catalog Number CD8450 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic proc
Terminated		 GBWK926477
Jun 27, 2016ConMed Corporation
CORE Trumpet Handpiece with 5mm x 32cm Length Probe , Catalog Number CD8400 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy an
Terminated		 GBWK926477
Jun 27, 2016ConMed Corporation
CORE Suction Irrigation Handpiece without Probe for Single Solution or Dual Bags, Catalog Number CD8302 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, lap
Terminated		 GBWK926477
Jun 27, 2016ConMed Corporation
CORE Suction Irrigation Handpiece without Probe for Single Solution Bags, Catalog Number CD8300 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopi
Terminated		 GBWK926477
Jun 27, 2016ConMed Corporation
CORE Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution or Dual Bags, Catalog Number CD8190 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological
Terminated		 GBWK926477
Jun 27, 2016ConMed Corporation
CORE Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution Bags, Catalog Number CD8185 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparosco
Terminated		 GBWK926477
Oct 14, 2015Teleflex Medical
Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93. To provide an access port into the peritoneal cavity.
Terminated		 GBWK992907
Aug 10, 2012Teleflex Medical
TAUT, Cholangiogram Catheter Intraducer, Peritoneal Catheter, Teleflex Medical, Research Triangle Park, NC. An introduction/drainage catheter accessory is intended to aid in the manipulation of or in
Terminated		 GBWNone listed
May 21, 2009Boston Scientific Corporation
Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# DESCRIPTION M001205501 SACKS SS/6FR/28CM (BX/5) M001205
Terminated		 GBWK811378
Feb 15, 2007Taut, Inc.
Taut Intraducer Peritoneal Catheter, 12 Fr x 10 Fr x 20.3 cm; a sterile, Rx peritoneal catheter for single use, individually packaged in a Tyvek/clear pouch; Taut Inc., 2561 Kaneville Ct., Geneva, IL
Terminated		 GBWK960883
Sep 13, 2006Boston Scientific Corp
Boston Scientific vanSonnenberg Sump with ''J'' Tip, 30 cm, 14Fr (4.7 mm), for percutaneous abscess and fluid drainage, single use only, sterile; UPN M001202010, REF/Catalog No. 20-201.
Terminated		 GBWK811378
Aug 25, 2004Arrow International Inc
Peritoneal Lavage Kits, Model number AK-09001
Terminated		 GBWNone listed
Aug 25, 2004Arrow International Inc
Peritoneal Lavage Kits, Model number AK-09000
Terminated		 GBWK811627

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