DRC · Class II · 21 CFR 870.1390

FDA Product Code DRC: Trocar

Leading manufacturers include Pressure Products Medical Device Manufacturing, LLC, Medical Device Technologies, Inc. and Medsurg Industries, Inc..

51
Total
51
Cleared
123d
Avg days
1977
Since
Declining activity - 0 submissions in the last 2 years vs 3 in the prior period

FDA 510(k) Cleared Trocar Devices (Product Code DRC)

51 devices
1–24 of 51
Cleared Jul 26, 2024
Accusafe Transseptal Guidewire (GTR31180, GTR31230)
K240246
Synaptic Medical Corporation
Cardiovascular · 178d
Cleared May 17, 2024
SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)
K241042
Pressure Products Medical Device Manufacturing, LLC
Cardiovascular · 30d
Cleared Sep 14, 2022
SafeSept® Transseptal Guidewire (SS-140)
K221707
Pressure Products Medical Device Manufacturing, LLC
Cardiovascular · 93d
Cleared Mar 23, 2022
PathBuilder Transseptal Needle
K212625
Shanghai Microport EP Medtech Co., Ltd.
Cardiovascular · 217d
Cleared Mar 05, 2021
SafeSept Blunt Needle
K210328
Pressure Products Medical Device Manufacturing, LLC
Cardiovascular · 29d
Cleared Feb 21, 2018
TSN Transseptal Needle
K172950
Pressure Products Medical Device Manufacturing, LLC
Cardiovascular · 148d
Cleared Feb 16, 2018
Needle Free Transseptal Cannula
K172934
Pressure Products Medical Device Manufacturing, LLC
Cardiovascular · 144d
Cleared Jan 08, 2014
SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE
K130843
Oscor, Inc.
Cardiovascular · 287d
Cleared Feb 07, 2013
BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208
K122587
St Jude Medical
Cardiovascular · 167d
Cleared Nov 14, 2008
SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE
K081986
Oscor, Inc.
Cardiovascular · 123d
Cleared Sep 13, 2007
BRK TRANSSEPTAL NEEDLE
K072278
St Jude Medical
Cardiovascular · 28d
Cleared Oct 11, 2002
MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM) SHIELDED ANGIOGTAPHY NEEDLE, SRAN18T71WR-5
K022117
Merit Medical Systems, Inc.
Cardiovascular · 102d
Cleared Apr 06, 1998
MANAN POTTS-COURNAND NEEDLE
K974742
Medical Device Technologies, Inc.
Cardiovascular · 108d
Cleared Apr 06, 1998
MANAN
K974743
Medical Device Technologies, Inc.
Cardiovascular · 108d
Cleared Apr 06, 1998
MANAN GWI GUIDE WIRE INTRODUCER
K974745
Medical Device Technologies, Inc.
Cardiovascular · 108d
Cleared Mar 18, 1993
ARROW-FISCHELL EXTENDED VASCULAR ACCESS NEEDLE
K924338
Arrow Intl., Inc.
Cardiovascular · 203d
Cleared Dec 20, 1991
DISPOSABLE ANGIOGRAPHY NEEDLE, MODIFICATION
K914985
E-Z-Em, Inc.
Cardiovascular · 58d
Cleared Jul 02, 1991
LAPAROSCOPIC TROCAR
K911483
United States Endoscopy Group, Inc.
Cardiovascular · 89d
Cleared Jun 15, 1989
AUTO SUTURE SURGIPORT DEPTH GUIDE AND SKIRT
K893707
United States Surgical, A Division of Tyco Healthc
Cardiovascular · 28d
Cleared May 19, 1989
DISPOSABLE ANGIOGRAPHY NEEDLES
K890209
E-Z-Em, Inc.
Cardiovascular · 122d
Cleared Jan 15, 1986
MEDSURG POTT-COURNAND NEEDLE
K854293
Medsurg Industries, Inc.
Cardiovascular · 82d
Cleared Jan 13, 1986
MEDSURG SELDINGER NEEDLE
K854294
Medsurg Industries, Inc.
Cardiovascular · 80d
Cleared Jul 20, 1981
VISITEC NEEDLE RANGE (CARDIOVASCULAR)
K811964
Visitec Co.
Cardiovascular · 10d
Cleared Aug 23, 1978
DILUTION KIT, THERMAL, COLD PAC
K781221
Instrumentation Laboratory CO
Cardiovascular · 37d

About Product Code DRC - Regulatory Context

510(k) Submission Activity

51 total 510(k) submissions under product code DRC since 1977, with 51 receiving FDA clearance (average review time: 123 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 3 in the prior period.